Career

Opportunities

JOB DESCRIPTION:

JOB TITLE: Quality Assurance Manager

DEPARTMENT: Quality Assurance

SUPERVISOR: Director of Quality Assurance and Regulatory Affairs

Description:

The Quality Assurance Manager will oversee and manage the operations and systems of the Quality Assurance Department in support of the manufacture, testing and release of finished Active Pharmaceutical Ingredients.

Responsibilities:

  • To ensure that all cGMP requirements are being met by all departments engaged in the development, manufacture, processing, packing, analysis, holding, or distribution of product.
  • Provide continuous and proactive QA oversight.
  • Develop any needed procedures for the Quality Assurance function.
  • Manage the Norac Pharma Document Control and Quality Systems function.
  • Administer the quality systems (e.g., change control, deviation system, internal audit program, supplier qualification program, training program, customer complaint program, etc.).
  • Ensuring that the employees within their respective section(s) have the education, training, and experience, or any combination thereof, to perform assigned functions.
  • Ensuring that the employees within their respective section(s) comply with the current Good Manufacturing Practices.
  • Host external audits by clients and regulatory agencies.
Job Duties:

  • Audit and review of raw materials, intermediates, final product analytical reports, and batch records.
  • Approval/rejection of labels, intermediates and finished product.
  • Review and approve any training curricula.
  • Inspection, verification and approval of all labeling and artwork.
  • Evaluate and approve investigations, and perform QA Assessments for quality systems (e.g., deviation system, OOS system, customer complaints, etc.).
  • The hiring and training of the Quality Assurance personnel.
  • Develop and provide GMP and Quality Systems training.
  • Interact with all Regulatory Agencies during the course of audits and/or other relevant interactions.
  • Schedule external client audits and coordinate internal resources necessary for the audit.
  • Perform Annual Product Reviews.
  • Perform internal and external audits as required.
  • Review and approval of documents such as SOPs, analytical methods, master batch records, specifications, and validation documentation.
  • Write and revise documentation, when appropriate.
  • Perform trending of product data and quality systems.
  • Supervise assigned Quality Assurance personnel.
Education / Experience / Personal Requirements:

  • Degree in Science, preferably in Chemistry or related field.
  • Minimum five years experience in a Quality Assurance position.
  • Good interpersonal and leadership skills.
  • Detail oriented with critical thinking skills.
  • Ability to operate in a decentralized environment.
  • Ability to manage multiple tasks and prioritize work.
  • Self-motivated with strong organizational and time management skills.
  • Proficient in Microsoft Office applications (advanced knowledge of MS Word and Excel is preferred).
  • Prior experience in MasterControl or electronic document management system a plus.

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JOB DESCRIPTION:

JOB TITLE: Finance Analyst

DEPARTMENT: Accounting

SUPERVISOR: Director of Finance

Description:

Assists the Director of Finance in managing the company’s accounting functions including establishing and maintaining the company’s accounting principles, practices, and procedures. Prepare annual budgets and other financial operating reports as directed, and presents findings and recommendations to the Director of Finance. Responsible for managing the general accounting function and oversees the monthly accounting close process. Support the year-end audit process by providing auditors with requested schedules and hosting on-site visits during fieldwork. Maintain the fixed assets tracking system and provide asset and tax depreciation calculations for auditor’s tax filing. Support the Director of Finance and/or external CPA firm with the preparation of income tax returns, property tax statement, licenses & permit renewals & other state tax filings and provide support to periodic audits from government entities.

Job Duties:

  • Responsible for the General Ledger activities:
    • Supervise the accounts payable and accounts receivable (i.e. contracts administer) accounting staff.
    • Facilitate the monthly closing process
    • Maintain the monthly payroll posting templates in coordination with the human resource manager.
    • Calculate the monthly inventory valuation.
    • Calculate monthly fixed asset depreciation expense.
    • Calculate monthly-prepaid insurance amortization expense.
    • Calculate monthly utilities expense allocation.
    • Calculate the quarterly Project Percentage of Completion revenue adjustment.
    • Prepare all necessary journal entries to record payroll, benefits, depreciation, accruals, allocations, interest expense, etc.
    • Prepare or review monthly analysis for all balance sheet accounts and update all accounts in the monthly close folders on the file server.
    • Review all other balance sheet account analyses to ensure each provides the balance composition and are in the proper format. Clear all errors in the accounts no later than 1 month after close.
    • Share inter-company balance details with parent company.
    • Review Trial Balance Summary and compare P&L results to budget. Provide explanations for all significant variances.
    • Manage QuickBooks Enterprise accounting system and maintain chart of accounts.
    • Adheres to current Good Manufacturing Practices (cGMP’s).
    • Writing of development reports for presentation to upper management and clients.
    • Verbal interaction with clients to discuss scientific results.
  • Manage various tax & license filings:
    • Coordinate with external tax accountant to ensure timely income tax payments to both Federal and State agencies.
    • Complete and submit annually the California 571L property tax statement. Review assessed property values and trends with county assessor as required.
    • Review the quarterly Sales and Use tax return prepared by the accounts payable clerk and filed with the California State Board of Equalization.
    • Represent company during audits of the California Board of Equalization for sales and use tax filing and Los Angeles County for property tax filings.
  • Year-end Financial Audit and Mid-year Review:
    • Coordinate and support activities for the annual financial audit.
    • Prepare various audit schedules as requested by the external auditors.
    • Host and support the external auditors during the fieldwork.
    • Record adjusting journal entries and ensure company’s general ledger agrees to the audited financial statements.
  • Fixed Asset System:
    • Post all fixed asset activity in asset tracking log.
    • Process assets additions and retirements.
    • Calculate and record monthly depreciation.
    • Reconcile asset and depreciation balances in the tracking log to the trial balance as part of the monthly analysis work.
    • Prepare monthly and annual fixed asset reports and tie to trial balance.
    • Determine proper accounting treatment for asset purchases in accordance with company policy and GAAP accounting.
  • Budget and Forecasting:
    • Support the annual budget process by timely preparing the Excel Budget model and working with management to gather information and populate the schedules.
    • Summarize budget reporting and present to management.
    • Prepare and distribute monthly actual vs. budget analysis reports to managers.
    • Conduct monthly reviews with managers to document variances to ensure accountability.
  • Cash Flow Management:
    • Initiate bank wire transfer instructions as required.
    • Review the cash position report on a daily basis and maintain a cash flow forecast with a 6-month horizon.
  • Miscellaneous Analysis and Reporting:
    • Create and generate relevant monthly financial management information reporting.
    • Assist with the coordination, monitoring and management of the company’s Compliance Tool for tracking government filings and other requirements.
    • Assist and act as backup for payroll processing as needed.
    • Mentor and provide training and assistance to accounting staff.
    • Prepare post project profitability reports for completed R&D contracts.
    • Other tasks and responsibilities as assigned by the Director of Finance.
  • Education & Experience:
    • Bachelors degree in Accounting or Finance.
    • +3 years of Accounting related experience. Preferably in pharmaceutical R&D and/or manufacturing environment.
    • +1 year Audit experience.

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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 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 BS/MS/PhD degree in chemistry?
  • experience in cGMP Active-Pharmaceutical-Ingredient (API) process scale up and process development is preferred?
  • 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 process chemist with good communication skills.

When applying please specifically list:

      1. Your degree (with need for Bachelors, Masters or Doctorate qualifications in synthetic organic chemistry)
      2. Years of experience (ideally with at least 2 years 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 Process Research and Development

DEPARTMENT: Process Research and Development

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

Description:

With minimal supervision, the Process Research and Development Senior Chemist performs 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:
    • Develop and validate new process chemistry or exploit and validate established process chemistry for synthetic organic chemical reactions.
    • Conduct thorough literature reviews to assess feasibility of proposed route of synthesis and offer alternative approaches.
    • Generate unforeseen insights into chemical reactions and procedures under development.
    • Scale-up of new products from gram quantities to production quantities in both Kilo Lab and Pilot Plant.
    • 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.
    • Teach and mentor junior staff with possibility of a supervisory role.
    • Prepare novel compounds with optimized chemical and/or physical properties.
    • Reasonable ability to interpret via modern spectroscopic tools (IR, NMR (H,C,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 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 using 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 regulatory and controlled documentation.
    • Adheres to current Good Manufacturing Practices (cGMP’s).
    • Writing of development reports for presentation to upper management and clients.
    • 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.

Education / Experience / Personal Requirements:
  • B.Sc. degree in chemistry with 15+ years work experience in basic chemistry laboratory technology in industry with practical hands-on knowledge of general chemistry.
  • M.Sc. degree in chemistry with 5+ years work experience in basic chemistry laboratory technology in industry with practical hands-on knowledge of general chemistry.
  • Entry level Ph. D degree in chemistry
  • Detailed experience in scale-up of a variety of synthetic organic transformations.
  • Familiarity and experience with a some of the analytical equipment such as HPLCs, GCs, and usual organic spectroscopic instrumentation.
  • Preliminary knowledge of cGMP/GLP principles and the ability to apply the principles.
  • 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 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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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.