The Specialist in Chemistry is responsible for supporting the manufacturing process of Rx and OTC pharmaceutical products in Waco. Knowledge of GMPs and technical writing skills.
This position is responsible for the following:
- Provides technical assistance to the Chemistry Laboratory staff for the execution of Validation Protocols covering laboratory operations and manufacturing support in relation to raw materials in process and finished products.
- Conducts investigations on out of specification test results.
- Organizes and may perform 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.
- Interfaces with QA counterparts to optimize laboratory support of QA and production activities.
- Works effectively with chemists to complete special sample analyses as required.
- Performs other duties as assigned and assists on special projects 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:
Bachelor’s Degree with an emphasis in Chemical or related science.
Five (5) years of experience in pharmaceutical manufacturing chemistry lab or similar laboratory experience.
Intermediate user knowledge of Microsoft Office. Experience with LIMS and Trackwise preferred.
Experience working in a GMP regulated environment preferred.
Experience working in an aseptic environment preferred.
Essential Knowledge, Skills & Abilities:
- Excellent analytical skills and problem-solving skills.
- Strong math skills, including the comprehension of metric weights and measures, performing complex calculations, and spreadsheet management.
- Ability to perform detailed tasks and document activities accurately.
- Able to work in an aseptic controlled environment which includes wearing PPE, aseptic gowning qualifications, and subsequent gowning requalification’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.
- Intermediate user knowledge and understanding of Windows based computer systems such as Microsoft Office, with an ability to learn other computer-based systems. Experience with SAP preferred.
- Strong written and verbal communication skills.
- Ability to work with minimal supervision.
- Ability to provide direction for functional area.
- 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.
Significant Work Activities: N/A
Job Type: Experienced