Career

Opportunities

Position:

JOB TITLE: Quality Assurance Specialist

DEPARTMENT: Quality Assurance

SUPERVISOR: Quality Assurance Manager

Description:

The Quality Assurance Specialist will support the Quality 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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    Position:

    JOB TITLE: Chemist, Process Research and Development

    DEPARTMENT: Process Research and Development

    SUPERVISOR: Senior Chemist, Senior Chemist I, Senior Chemist 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: Accounting Clerk

    DEPARTMENT: Accounting

    SUPERVISOR: Accounting Manager

    Description:

    The Accounting Clerk’s areas of responsibility include coordination of company shipments, client invoicing, accounts receivable monitoring, and front office support.

    Responsibilities:

    • SHIPPING
      • Coordinate outbound shipments according to the company policy and procedures.
      • Obtain DOT & IATA Hazmat Shipping certification.
    • CONTRACT MONITORING AND INVOICING
      • Monitor service contract billing milestones and related project materials.
      • Monitor project spending variances.
      • Prepare service invoices and issue upon approval.
      • Prepare material charge invoices and issue upon approval
      • Coordinate with project leaders to ensure vendor invoices are coded to the proper projects and make adjustments for sales taxes when required.
      • Prepare and issue project financial reports to Project Leaders.
      • Monitor customer accounts receivable. Contact customers regarding past-due invoices and report collection status to management
      • Fulfill Customer Service tasks including:
      • Order entry.
      • Coordinate with coworkers in production, quality and shipping.
      • Coordinate with customers regarding deliveries.
      • Establish and update project financial tracking reports using the company provided forms.
      • Portfolio meeting: prepare project slides for a monthly project review meeting and circulate post-meeting action items and notes.
    • FRONT OFFICE SUPPORT
      • Cover front desk (greet visitors, provide visitor badges, answer phones, monitor staff going off site, etc.) when the receptionist is absent or at lunch.
      • Prepare and print labels for lab chemical inventories.
      • Maintain Confidential Disclosure Agreements (CDA) for clients and vendors in document management system.

    Education / Experience / Personal Requirements:

    • 2 years experience in an administrative, clerical or bookkeeping role
    • Accounting/Bookkeeping coursework, preferred
    • Experience with QuickBooks preferred
    • Proficiency with Microsoft Office (Excel/Word)
    • Meet commitments timely and manage expectations
    • Exhibit close attention to detail and maintain an organized work space

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    Position

    Senior Process Chemist

    Salary compensation commensurate with experience.

    Norac Pharma is looking to hire an experienced Process Chemist to join our team of dedicated professionals involved in Active Pharmaceutical Ingredient (API) research, development and manufacture at our Azusa California site. The candidate that we recruit will ultimately be responsible for developing safely scalable processes for manufacture of existing API’s, as well as new medicines to benefit patients worldwide. These manufactures will be implemented in our Kilo Lab, Pilot Plant and Commercial Manufacturing facilities. The position requires the individual to provide technical leadership in performing synthetic chemistry experiments for understanding, developing and validating process chemistry for new and/or established products and projects, characterizing reaction products utilizing appropriate methodology and maintaining laboratory records in accordance with cGMP practices and requirements. Norac Pharma is a California-based API contract research, development and manufacturing facility located in Azusa California, just east of Pasadena, at the foothills of the San Gabriel Mountains. The region offers numerous hiking trails, as well as being ideally located for travelling to the beaches in the summer and to the mountains with skiing in the winter, in addition to providing easy access to superb arts, culture and a myriad of other social/leisure facilities and opportunities. We believe that the long-term success of Norac Pharma depends first and foremost on recruiting and retaining the highest quality personnel, as well our cooperative cross-functional working thanks to our relatively small size of around 70 staff at this location, albeit with ongoing investment and growth and with strong supporting financial security. Norac Pharma enjoys world class facilities with state of the art analytical equipment which our scientists use for effective and efficient process design (detailed below). Apart from this breadth of analytical equipment, Norac Pharma has a variety of other process tools to aid in developing safe, scalable, robust processes (detailed below). We encourage diversity along with close and cooperative project team collaboration on each and every project.

    Requirements:

  • M.Sc. degree in chemistry with at least 7 years of relevant work experience in the synthesis and manufacture of active pharmaceutical ingredients and/or Ph.D. degree in chemistry with at least 3 years of relevant work experience in the synthesis and manufacture of active pharmaceutical ingredients
  • Hands-on experience in the development and scale-up of a variety of synthetic organic transformations at multi-kilogram scale
  • Practical experience in the techniques and procedures of synthetic organic chemistry including spectroscopy, chromatography, handling air-sensitive agents, etc
  • Excellent interpersonal skills with an ability to work as part of a multi-disciplinary team, with the ability to manage, prioritize and coordinate activities with cross-functional departments
  • Self-motivated with strong organizational and time management skills
  • Hands-on experience with a variety of analytical spectroscopic equipment such as HPLCs, GCs, for organic reaction analysis
  • Clear writing and communication skills
  • Demonstration of previous project managerial experience and team leading experience
  • Ideally has a working knowledge of cGMP principles and the ability to apply them Experience with a range of chemical calculations
  • Computer literacy including practical experience with Excel, Word, Powerpoint, Outlook, Chemdraw or equivalent software
  • A careful observer dedicated to maintaining comprehensive experimental records including diligent lab notebook recording of work
  • Demonstration of understanding the mechanisms of reactions and reaction kinetics as a predictor of control and scale up
  • A working knowledge in the use of factorial experimental design software to aid process optimization is preferred Responsibilities:

  • Develop and validate new process chemistry or evaluate and validate established process chemistry for synthetic organic chemical manufactures
  • Scale-up of new products from gram quantities to multi-kilo to tonnage scale manufacture in our Kilo Lab, Pilot Plant and Commercial Products Facilities
  • Take on Project Leader responsibilities and management of workload vs. project timelines to complete projects on time, within budget and achieving the desired quality
  • Generate insights into chemical reactions and procedures under development
  • Obtain scale-up kinetic and thermodynamic experimental data defining controlling variables by performing periodic removal, quenching (if required) and analysis of aliquots
  • Conduct thorough literature reviews to identify and assess feasibility of proposed route(s) of synthesis
  • Write and present development reports to upper management and clients
  • Verbal interaction with clients to discuss scientific results
  • Prepare novel compounds and characterize them using modern spectroscopic tools (IR, NMR (1H, 13C,1-D,2-D), UV-Vis, MS)
  • Generate gram quantities of high-purity samples of key intermediates, most often by chromatography, recrystallization, sublimation, and/or fractional distillation
  • Maintain laboratory records in accordance with accepted good laboratory practices, SOPs, and regulatory requirements
  • Teach and mentor junior staff with possibility of supervisory management role
  • Assist with the preparation/review of regulatory and controlled documentation
  • Adhere to current Good Manufacturing Practices (cGMP)
  • Actively support the Environmental, Health & Safety programs of Norac Pharma to ensure employee, plant and community safety and security
  • 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.
  • Ensure compliance with OSHA and other safety regulations (e.g., hot work, lock out tags, confined work space, etc.).
    Analytical Equipment at Norac Pharma:

  • Waters and Agilent HPLC’s with a variety of detectors (UV-Vis, PDA, Refractive Index, Charged Aerosol)
  • UPLC with Q-TOF Mass Spectrum
  • Bruker 400MHz NMR
  • Inductive Coupled Plasma Mass Spectrometry (ICP-MS)
  • Gas Chromatography (Direct Injection, Head-Space GC, Mass Spectrum)
  • Malvern Mastersizer for particle size analysis
  • Air Jet Sieve methodology for particle size analysis
  • X-Ray Powder Diffraction
  • Polarimeter
  • Total Organic Carbon analyzer for fast turnaround for cGMP equipment cleaning verification
  • Dynamic Vapor Sorption for determining solvent uptake
  • Thermal Gravimetric Analysis
  • Differential Scanning Calorimetry for thermal analysis of samples
  • Morphologi for particle size and shape analysis and visualization
  • Ion Chromatography
  • UV determination
  • Karl Fischer for water determination
  • Infrared analysis
  • Autotitrators
    Process Research and Development Equipment at Norac Pharma

  • ReactIR for real time in-situ reaction monitoring
  • Teledyne ISCO for chromatographic separations
  • Focused Beam Reflectance Measurement for real time in-situ crystallization monitoring
  • RC-1 calorimetry
  • Advanced Reactive System Screening Tool for process safety assessment
  • EasyMax for automated reaction execution and monitoring
  • Fisher-Porter bottles
  • Asynt multi-tube autoclave for pressure reaction screening
  • Multi-well reaction blocks for quick screening of reactions
  • Autoclaves for scale up of pressure reactions
  • Optical microscope
  • Standard laboratory equipment for reaction monitoring (e.g. J-Kem thermocouples and vacuum controllers, overhead stirrers, jacketed reactors, heater/chiller units, rotary evaporators etc.)

    To apply please submit resumes to resumes@noracpharma.com

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