Career

Opportunities

JOB DESCRIPTION:

JOB TITLE: Document Control Associate

DEPARTMENT: Document Control / Quality Assurance

SUPERVISOR: Quality Assurance Manager

Description:

The Document Control Associate is responsible for processing, issuance and archival of all documentation generated in support of the manufacture, testing and release of finished Active Pharmaceutical Ingredients in a manner intended to ensure that the API products meet the requirements of regulatory agencies, internal company standards and industry current practices.

Responsibilities:

  • Issuing execution paper forms as requested.
  • Tracking of checked-out documentation.
  • Issuance of logbooks and laboratory notebooks.
  • Issuance, tracking, and archival of execution batch records.
  • Control and archival of pharmaceutical documentation (validation studies, stability, etc.)
  • Data retrieval for internal and external audits.
  • Administrative duties such as scanning, filing and photocopying.
  • Document Control projects as assigned.
  • Additional Quality Assurance functions as assigned.
  • Participate in Quality Assurance inspection responsibilities.
  • Administer and maintain the Work Order program.
  • Issue and track work orders for all maintenance and calibration activities.
  • Back-up for the EDMS System Administrator.

Education / Experience / Personal Requirements:

  • Associate Degree (minimum requirement), Bachelor’s Degree preferred.
  • Five years experience in Quality Assurance or Document Control position in a Pharmaceutical, Medical Device, or Biologic Company.

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JOB DESCRIPTION:

JOB TITLE: Quality Assurance Specialist

DEPARTMENT: Quality Assurance

SUPERVISOR: Quality Assurance Manager

Description:

The Quality Assurance Specialist will support theQuality Assurance department and the entire organization with review of Production Batch Records and Analytical Test Reports and release of raw materials. This position additionally will support Regulatory Affairs with document review, analytical calculations, organization, and assembling documents for regulatory submissions. Furthermore, this position will be involved in the quality oversight for the manufacture, testing and release of finished Active Pharmaceutical Ingredients.

Responsibilities:

  • Under the direction of the Quality Assurance Manager, the Quality Assurance Specialist ensures that applicable cGMP requirements are being met by all departments engaged in the development, manufacture, processing, packing, analysis, holding, or distribution of product.
  • Organize and perform review of Production Batch Records and Analytical testing reports to ensure timely release of finished API’s.
  • Perform production line clearance and assist in investigative documentation.
  • Perform label and final product inspection.
  • Review raw material data package for release
  • Apply approved label on released raw materials and final product. Develop any needed procedures for the Quality Assurance Unit.
  • Assist the Quality Assurance Manager in other QA related activities.

Job Duties:
  • GMP understanding, awareness, and enforcement.
    • Duties include constant awareness of GMP behavior throughout the facility and documentation.
    • Report any and all GMP deficiencies immediately to the QA Manager.
  • Ensure that employees within their respective section(s) comply with the current Good Manufacturing Practices.
  • Review and release intermediates and finished product analytical reports and batch records.
  • Review and approval of monitoring data (e.g., stability, water system, solvent system).
  • Review of raw material release package.
  • Inspection, verification, and issuance of all labeling and artwork.
  • Write and revise documentation, when appropriate.
  • Participate in Quality Review Report distribution.
  • Perform other QA related functions as directed by the Quality Assurance Manager.

Education / Experience / Personal Requirements:

  • A Bachelors Degree in a scientific discipline is required, preferably Chemistry.
  • Minimum five years experience in a Quality Assurance or Quality Control position in a GMP environment, preferably API manufacturing facility.
  • Proficient in Microsoft Office applications (advanced knowledge of MS Word and Excel is preferred).
  • MasterControl experience is highly desired.

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Are you a Process Research and Development Chemist with:

  • with a BS/MS degree in chemistry (required)
  • and basic chemistry laboratory experience

Do you enjoy practical chemistry problem solving and working on a variety of projects in a collaborative team environment

Are you interested in Working with a long established, world leading active pharmaceutical ingredient contract development and manufacturing organization noted for solving tough chemical process challenges and providing unbeatable customer service, located in the beautiful surroundings of Azusa, California, within short access to spectacular hiking and beaches and benefiting from year-round warm California climate.

If so, Norac Pharma is looking for an additional synthetic organic chemist to support our expanding API process R&D team.

When applying please specifically list:

      1. Your degree (with need for Masters or Doctorate qualifications in synthetic organic chemistry)
      2. Details of experience
      3. Your available start date
Please visit the career section of our website at www.noracpharma.com for a detailed job description.
Qualified candidates meeting the 3 criteria listed above are invited to submit their resume and supporting letter by email to:  resumes@noracpharma.com     
If you need assistance in applying for this or any other position with Norac Pharma, please contact our Human Resources Department at 626-334-2908 and direct assistance will be provided.
Norac Pharma is an Equal Opportunity Employer: Minorities/Female/Disabled/Veteran

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JOB DESCRIPTION:

JOB TITLE: Chemist, Process Research and Development

DEPARTMENT: Process Research and Development

SUPERVISOR: Senior Chemist, Senior Chemist I, Senior Chemist II, Projects Leader, Projects Leader I, Projects Leader II, Principal Scientist or Senior Principal Scientist, Process Research and Development

Description:

The Process Research and Development Chemist under supervision will perform synthetic chemistry experiments to assist in developing and validating process chemistry for new and/or established products and projects, characterizing reaction products and intermediates with appropriate methods and maintaining laboratory records in accordance with cGMP/GLP practices and requirements.

Responsibilities:

  • Primary Responsibilities:
    • Under supervision assist in developing and validating new process chemistry and exploiting and validating established process chemistry for synthetic organic chemical reactions.
    • Under supervision assist with the scale-up of new products from gram quantities to production quantities.
    • Prepare novel compounds with optimized chemical and/or physical properties.
    • Generate gram quantities of high-purity samples of key intermediates, most often by chromatography, recrystallization, and/or ambient/reduced pressure distillation.
    • Perform routine characterization of reaction products and intermediates by both wet and instrumental methods.
    • Maintain laboratory records in accordance with accepted cGMP/GLP laboratory practices, SOPs, and regulatory requirements.
    • Assist with review of GMP-related (i.e., controlled) documentation.
  • Safety Responsibilities:
    • Actively support the Environmental, Health & Safety programs of Norac Pharma to ensure employee and plant safety and security.

Education / Experience / Personal Requirements:

  • B.Sc. degree in chemistry or equivalent
  • Preferably, experience with basic chemistry laboratory technology and practical hands-on knowledge of general chemistry.
  • Basic experience in a variety of synthetic organic transformations is helpful.
  • Knowledge of broad based cGMP/GLP principles and the ability to apply said principles is helpful.
  • Ability to perform a range of chemical calculations.
  • Some practical experience in the techniques and procedures of modern organic chemistry including spectroscopy, chromatography, handling air-sensitive agents, etc.
  • Basic computer literacy (knowledge of Excel or other spreadsheet programs recommended).
  • A high degree of patience.
  • A strong commitment to mastering advanced laboratory techniques.
  • Good interpersonal skills in a decentralized environment.
  • A careful observer dedicated to maintaining professionally valid records including lab notebooks.
  • Intellectually inquisitive.
  • Self-motivated.
  • Good at following instructions and asking pertinent questions.

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JOB DESCRIPTION:

JOB TITLE: Chemist II Process Research and Development

DEPARTMENT: Process Research and Development

SUPERVISOR:Senior Chemist, Senior Chemist I, Senior Chemist II, Projects Leader, Projects Leader I, Projects Leader II, Principal Scientist, Senior Principal Scientist, Process Research and Development

Description:

The Process Research and Development Chemist will perform synthetic chemistry experiments to assist in developing and validating process chemistry for new and/or established products and projects, characterizing reaction products and intermediates with appropriate methods and maintaining laboratory records in accordance with cGMP/GLP practices and requirements.

Responsibilities:

  • Primary Responsibilities:
    • Assist and contribute to developing and validating new process chemistry and exploiting and validating established process chemistry for synthetic organic chemical reactions.
    • Generate unforeseen insights into chemical reactions and procedures under development.
    • Some mentoring of junior staff.
    • Assist and contribute with the scale-up of new products from gram quantities to production quantities.
    • Reasonable ability to interpret data via modern spectroscopic tools (IR, NMR (H,C,1-D,2-D), UV-Vis, MS)
    • Prepare novel compounds with optimized chemical and/or physical properties.
    • Generate gram quantities of high-purity samples of key intermediates, most often by chromatography, recrystallization, and/or ambient/reduced pressure distillation.
    • Obtain scale-up kinetic and thermodynamic experimental data involving controlled variables by performing periodic removal, quenching (if required) and analysis of aliquots.
    • Perform routine characterization of reaction products and intermediates by both wet and instrumental methods.
    • Ability to distinguish between expected and unexpected experimental results.
    • Maintain laboratory records in accordance with accepted cGMP/GLP laboratory practices, SOPs, and regulatory requirements.
    • Assist with the preparation / review of GMP-related (i.e., controlled) documentation.
    • Adheres to current Good Manufacturing Practices (cGMP’s).
    • Ability to write detailed reports and present results to upper management and clients when required.
  • Safety Responsibilities:
    • Actively support the Environmental, Health & Safety programs of Norac Pharma to ensure employee and plant safety and security.

Education / Experience / Personal Requirements:

  • B.Sc. in Chemistry (or equivalent) with 5+ years of experience
  • M.Sc. in Chemistry
  • Experience with basic chemistry laboratory technology and practical hands-on knowledge of general chemistry.
  • Detailed experience in scale-up of a variety of synthetic organic transformations.
  • Knowledge of broad based cGMP/GLP principles and the ability to apply said principles is helpful.
  • Ability to perform a range of chemical calculations.
  • Practical experience in the techniques and procedures of modern organic chemistry including spectroscopy, chromatography, handling air-sensitive agents, etc.
  • Basic computer literacy (knowledge of Excel or other spreadsheet programs recommended).
  • A high degree of patience.
  • A strong commitment to mastering advanced laboratory techniques.
  • Good interpersonal skills in a decentralized environment.
  • A careful observer dedicated to maintaining professionally valid records including lab notebooks.
  • Intellectually inquisitive.
  • Able to manage multiple tasks and prioritize work.
  • Self-motivated with strong time management skills.

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Are you a Process Research and Development Chemist with:

  • a MS/PhD degree in chemistry?
  • experience in cGMP Active-Pharmaceutical-Ingredient (API) process scale up and process development?
  • management experience in supervising and directing multiple projects and project teams?
  • excellent communication and organizational skills?

Do you enjoy practical chemistry problem solving and working on a variety of projects in a collaborative team environment?

Are you interested in working with a long established, world leading active pharmaceutical ingredient contract development and manufacturing organization noted for solving tough chemical process challenges and providing unbeatable customer service, located in the beautiful surroundings of Azusa, California, within short access to spectacular hiking and beaches and benefiting from year-round warm California climate.

If so, Norac Pharma is looking for an additional experienced process chemist working with excellent team management and communication skills

When applying please specifically list:

      1. Your degree (with need for Masters or Doctorate qualifications in synthetic organic chemistry or biochemistry)
      2. Years of experience (with at least 5 years experience of process chemistry R&D and scale-up experience)
      3. Your available start date
Please visit the career section of our website at www.noracpharma.com for a detailed job description.
Qualified candidates meeting the 3 criteria listed above are invited to submit their resume and supporting letter by email to: resumes@noracpharma.com
If you need assistance in applying for this or any other position with Norac Pharma, please contact our Human Resources Department at 626-334-2908 and direct assistance will be provided.
Norac Pharma is an Equal Opportunity Employer: Minorities/Female/Disabled/Veteran

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JOB DESCRIPTION:

JOB TITLE: Senior Chemist II Process Research and Development

DEPARTMENT: Process Research and Development

SUPERVISOR: Projects Leader, Projects Leader I, Projects Leader II, Principal Scientist, Senior Principal Scientist, Group Leader, Senior Group Leader, Associate R&D Director or Director, Process Research and Development

Description:

The Process Research and Development Senior Chemist II provides technical leadership to perform synthetic chemistry experiments developing and validating process chemistry for new and/or established products and projects, characterizing reaction products and intermediates with appropriate methods and maintaining laboratory records in accordance with cGMP/GLP practices and requirements.

Responsibilities:

  • Primary Responsibilities:
    • Assist in evaluating the feasibility of synthesizing compounds that may be brought to Norac Pharma.
    • Develop and validate synthetic lab and pilot plant processes to produce a variety of organic and organometallic compounds.
      • Conduct relevant literature searches.
      • Develop lab scale procedures for the syntheses of organic compounds.
      • Optimize the procedure to improve yields in the syntheses of organic compounds.
      • Scale up the lab process to produce pilot plant and production quantities of the compounds in accordance with cGMP requirements.
      • Write Development Reports on synthesis and scale up projects per cGMPs.
      • Maintain complete laboratory records in accordance with accepted laboratory practices, SOPs, and regulatory requirements.
      • Develop analytical methodologies.
    • Monitor yield and efficiencies of processes after commercial startup at the plant.
    • Help establish necessary practices to ensure GLP/cGMP compliance.
    • Take on Project Leader responsibilities and manage the work load vs. project timelines to complete projects on time, within budget and achieving the desired quality.
    • May provide direct supervision to junior staff as well as work in a mentoring role. Acts as peer review for work of others, consistent with training.
    • Assist with the preparation / review of controlled and regulatory documents.
    • Work with contract organizations as necessary.
    • Adheres to current Good Manufacturing Practices (cGMP’s).
    • Verbal interaction with clients to discuss scientific results.
  • Safety Responsibilities:
    • Actively support the Environmental, Health & Safety programs of Norac Pharma to ensure employee and plant safety and security.
    • Perform a critical review of the processes to determine potential risk and make recommendations to mitigate the risks.
    • Work with management, technical personnel, and EHS director to ensure any new process or changes to existing processes follow OSHA PSM guidelines.
    • Ensure compliance with OSHA and other safety regulations (e.g., hot work, lock out tags, confined work space, etc.).

Education / Experience / Personal Requirements:

  • M.Sc. in Chemistry (or equivalent) with 15+ years of work experience in the synthesis and manufacture of active pharmaceutical ingredients.
  • Ph.D. in Chemistry (or equivalent) with 5+ years of work experience in the synthesis and manufacture of active pharmaceutical ingredients.
  • Hands on experience with a variety of analytical equipment such as HPLCs, GCs, and usual organic spectroscopic instrumentation.
  • Displays excellent working knowledge of cGMP/GLP principles and able to apply the principles.
  • Excellent interpersonal and leadership skills
  • Ability to operate in a decentralized environment.
  • Self-motivated with strong organizational and time management skills.
  • Demonstration of previous managerial experience and/or team leading experience is preferred.
  • Ability to work as part of a multi-disciplinary team and coordinate activities with cross-functional departments.

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JOB DESCRIPTION:

JOB TITLE: Chemist II Quality Control

DEPARTMENT:Quality Control

SUPERVISOR:Team Leader Quality Control

Description:

The Quality Control Chemist will perform release testing at all stages of chemical manufacture including raw material, in-process and finished product as well as perform analytical method validation, cleaning verification and stability testing according to newly developed and established protocols as well as assisting Analytical R & D Chemists to develop analytical methods suitable for validation on an as-needed basis.

Responsibilities:

  • In a team setting and cGMP environment, under routine supervision, performs the physical and chemical testing of raw materials, materials in-process, and finished products to assess conformance to applicable standards.
  • Ensures the commercial laboratory testing process is well defined, adheres to current Good manufacturing Practices (cGMP), all equipment are appropriately qualified for analytical testing.
  • Prepares and standardizes test/volumetric solutions, standard solutions and samples for various chemical and physical test according to approved methods, perform and lead others in performing complex analyses including, but not limited to HPLC, GC, IC, UV-Visible Spectrophotometry, FTIR, and Karl Fischer
  • Responsibilities include peer review, evaluate and investigate results from various analyses and accountable for identifying trends and reoccurring issues. Additionally prepare, organize and final review paperwork and lab results for lot release to ensure accuracy and completeness, represent the team as a leader in problem solving, troubleshooting and documentation related to laboratory investigations.
  • Responsible for scientific leadership within the Analytical QC laboratory performing method verification, troubleshooting, and USP method verification. Suggest alternative methods, processes and procedures in solving problems and meeting changing laboratory opportunities. Review technical problems and procedures within the laboratory and recommend solutions to problems or changes in procedures.
  • Experience with Method Validation and Qualification activities, including protocol development, execute protocols and write summary reports.
  • Comply with Norac Pharma’s policies, procedures, quality standards as well as safety and environmental regulations. This individual will assure compliance with all US (e.g. FDA Guidelines, USP, cGMP) and compliance requirements.
  • Maintain working knowledge of assigned instrumentation, equipment, and operating procedures necessary to perform assigned tasks.
  • Prepare and execute stability protocol, initiate stability study and prepare interim and final reports detailing results of protocol execution.
  • Perform cleaning method validation and write cleaning validation reports.
  • Perform the following as needed:
    • Method transfer in-house and from clients
    • Method verification
    • Evaluate and validate client methods
    • In house methods validation, including contract and commercial products
    • Material and standard qualification
    • Routine lab instrument calibration
  • Perform day to day general lab activities e.g. sampling raw materials and in-process testing, cleaning lab glassware, monitoring stability chambers, maintaining cleanliness in the laboratory
  • Participate in analytical investigations and CAPA’s
  • Must be able to periodically lift and move bulky items of up to 50 pounds

Education / Experience / Personal Requirements:

  • Minimum 2-3 years in a Pharmaceutical Analytical Laboratory environment
  • Hands-on working experience of Laboratory Instrumentation (HPLC’s, GC’s, GC-Headspace, Ion Chromatography, FTIR, UV-Vis, KF, etc.)
  • Prior experience with characterization of raw materials, APIs and chemical impurities using FT-IR, UV-Vis, KF, ICP, NMR, LC-MS, GC-MS, Particle Size Analyzer and XRD is preferred
  • Knowledge and understanding of FDA, ICH, and USP requirements
  • Excellent interpersonal, communication and organizational skills
  • Excellent computer proficiency and technical writing skills
  • Degree in Science, preferably in Chemistry or related field

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Thank you for your interest in Norac Pharma however we regret that we are unable to acknowledge all submissions and only those candidates who we invite for interview will be considered to be confirmed applicants.