The QC Chemistry Laboratory Technician III supports the manufacturing process of Rx and OTC pharmaceutical products in Waco by performing chemical testing on raw materials, stability studies, in process and finished product samples.
This position is responsible for the following:
- Organizes and performs testing of raw materials (including USP water), bulk samples, and finished product to assure the chemical quality of the product.
- Evaluates stability of raw materials, bulk samples, and finished product per established protocols.
- Maintains accurate notebook of all sample identifications, raw data, and calculations associated with assigned analysis duties.
- Reports anomalies in analyses and malfunctions of equipment to laboratory supervisor.
- Works effectively with chemists to complete special sample analyses as required.
Incumbent has full authority to make decisions and/or take action that is required to carry out job duties. Internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements and objectives. The incumbent must be willing to take temporary assignments as required.
Regulated Responsibilities (including cGMP and EHS)
Incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.
Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.
Education and Experience:
Minimum requirements for this position are:
Associates Degree with an emphasis in Chemical science and two (2) years of related lab experience. Or,
Bachelor’s Degree in Chemistry.
One (1) Year of experience in pharmaceutical manufacturing chemistry lab or similar laboratory experience.
Intermediate Microsoft Office Skills. Experience with LIMS, QMS and Trackwise preferred.
Experience working in a GMP regulated environment preferred.
Essential Knowledge, Skills & Abilities:
- Ability to perform detailed tasks and document activities accurately.
- Able to work in a aseptic controlled environment which includes wearing PPE, aseptic gowning qualifications, and subsequent gowning re-qualification’s.
- Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts).
- Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment.
- Ability to read, comprehend, write, and communicate effectively in English.
- Basic user knowledge and understanding of Windows based computer systems such as Microsoft Office, with an ability to learn other computer-based systems.
- Strong written and verbal communication skills.
- Ability to work with minimal supervision.
- Physically able to continuously stand and walk.
- Physically able to lift up to 40 lbs. for men and 35 lbs. for women.
- Physically able to bend, climb, lift, squat, stoop, and stretch to reach frequently.