SCOPE OF POSITION

Supervise the Chemistry Laboratory including Chemistrypersonnel. Responsibilities of the Chemistry Laboratory include raw materialtesting, finish product testing, water testing, maintaining stability program,and overall maintenance / calibration of the laboratory. Assist with customercomplaint testing of retention / customer samples and validation projects.

Writing investigations and standard operating procedures,leading validation projects, review of test results for final release ofproduct, understanding cGMP’s and aseptic guidelines as well as otherregulatory requirements, supporting QA/QC during FDA audits, and enhancingcurrent laboratory methods and techniques.

PRIMARY RESPONSIBILITIES

• Ensure the raw material testing, bulk sample testing, finish product testing, and water testing are completed and reviewed in a timely manner.
• Manage the condition of the stability program to ensure the samples are tested accordingly with the schedule.
• Assist with customer complaints by checking and testing retention / customer samples.
• Ensures Quality Control Technician support manufacturing and testing activities to meet appropriate controls and compliance to Good Manufacturing Practices and Good Laboratory Practices.
• Responsible for evaluating through trend analysis the processes within the plant and recommend corrective action when necessary.
• Provides guidance, delegates task, sets priorities, coaches, cross trains, and assists in developing new hires.
• Establish technical test procedures/methods to meet chemistry requirements as needed.
• Generates, updates, and reviews procedures for all chemistry testing or test related functions to reflect regulatory changes, scientific advances in technique, new products and/or changes in products. Responsible for assuring that all laboratory manuals contain current procedures.
• Oversees the day to day maintenance in the laboratory and maintains all the supplies necessary to run the lab efficiently. Develops and maintains programs in the laboratory to comply with the GMP’s and GLP’s.
• Manage the Chemistry Laboratory instrument maintenance and calibration program.
• Maintain the laboratory inventory of chemicals, instruments, and supplies.
• Periodic logbook management and review of all documentation.
• Ensure all SOP’s and necessary documents are updated.
• Responsible for writing Quality Summary Dossiers for various products.
• Proposal for new equipment assets and disposal of outdated equipment assets.
• Assists in new test designs and developments for new products.
• Assists in new product designs, developments, and validation projects.
• Plan and organize all day-to-day test activities of Chemists and schedule job tasks as related to special projects.
• Assure all requirements for lot release are met for timely release of all finish products.
• Responsible for initiating and implementing corrective action steps, with notification to QC Manager, for areas of concern which may cause delay of finish product lot release.
• Responsible for contacting hazardous waste management company to dispose of hazardous waste, not including bio-hazard waste.
• Review all personnel time sheets.
• Participate in Management Review Meetings to update management on Chemistry Laboratory activities.
• Responsible for generating cost analysis on Chemistry Laboratory related activities.
• Responsible for maintaining and projecting Chemistry Laboratory budget costs.
• Participate in audits and validations when necessary.
• Assists with technical writing and any other activities assigned by the QC Manager.

REQUIRED SKILLS, KNOWLEDGE, ANDABILITIES

· Complies with all company policies andprocedures.

· Must be a team player and customer /results oriented.

· Comply with all company safety policiesand procedures to ensure a safe and healthy environment.

· Able to have flexible time to supportmanufacturing.

QUALIFICATIONS

• B.S. majoring in Chemistry or related science.
• Working knowledge of different analytical instrument, including HPLC, TOC, UV/VIS spectrometer, Infrared Spectrometer, pH meter.
• 5 years of experience in a chemistry laboratory of a pharmaceutical manufacturing environment. Pharmaceutical experience is required.
• Proficient in Microsoft Excel, Microsoft Word, and Microsoft PowerPoint.
• Strong verbal communication, proficient in technical writing, and excellent interpersonal skills are required.

MINIMUM REQUIREMENTS

· Preference: Normally receives no instruction on routinework and general instructions on new assignments. Have excellent attention todetails.

· Extensiveknowledge with Chormeleon software.

Extensiveand working knowledge of different analytical instrument, including HPLC, TOC,UV/VIS Spectrometer, Infrared Spectrometer, balance, pH meter, etc.

Job Type: Full-time

Pay: $66,000.00 - $70,000.00 per year

Schedule:

• 8 hour shift
• Day shift

Ability to Relocate:

• Pomona, CA 91768: Relocate before starting work (Required)

Work Location: In person