Conduct biological, chemical and physical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming raw material through finished goods including at a minimum; in-process, final container, stability and critical systems testing. Responsible for ensuring the daily operations of assigned functional area are met through scheduling, troubleshooting, and coaching. Must participate and/or drive completion of improvement projects and responsible milestones.
Essential Duties and Responsibilities
- Conduct biological, chemical and physical analyses on raw materials, stability, in-process samples and final products, and samples collected from systems monitoring programs, following controlled test procedures. Work under some Supervision.
- Use sophisticated laboratory instrumentation and computer systems to collect and record data. May perform advanced assays requiring precise analytical skills and understanding of biological and chemical principles.
- Perform review of test data with application of GDP.
- Complete all testing, including special project / protocol testing in a timely manner. Prepare and/or direct lab protocol studies under some supervision.
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Ensure data integrity and regulatory compliance is maintained in assigned area and/or system.
- Demonstrate familiarity with product specifications, process reference files, code of federal regulations, and compendia requirements.
- Use Global LIMS or other computerized systems for entering and approving test results.
- Actively contribute to a team setting within the laboratory and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.
- Ensure laboratory area is maintained in a GMP state at all times while following all EHS and 5S guidelines. Will be expected to do laboratory walk through to ensure area is suitable for hand off to oncoming shifts.
- Prepare and update SOPs as required under supervision
- Perform equipment maintenance and calibrations as required. May be the subject matter expert on assigned equipment.
- Drive Lean principles such as 5S throughout daily work activities.
- Ensure personal training requirements are met and that training records are current.
- May be required to perform microbial and particulate monitoring of clean rooms throughout the Manufacturing Facility for qualification purposes.
- May perform removal of hazardous waste.
- Other duties as assigned by departmental management.
- Ability to manage multiple tasks concurrently and drive tasks to completion in a timely manner.
- Computer literate and competent with a solid knowledge of word processing and spreadsheets (such as Microsoft Office).
- Must be detail-oriented, conscientious, and responsible.
- Capable of applying sound decision-making to problem-solve technical, compliance, or operational problems as assigned.
- Effective interpersonal communication and influencing skills. Must have effective verbal and written communication skills.
- Must have basic understanding of laboratory instrumentation and chemical handling.
- Working knowledge of applicable CTP/SOPs, EHS requirements, FDA Regulations, application of cGMP/GDPs and USP, JP, EP procedures.
- Must be able to learn new computer systems and programs in a timely manner.
Education and/or experience
Typically requires bachelor’s degree in chemistry, biological science, or other related technical field. Some related work experience preferred.
- Must be able to lift, push, pull and carry up to 25 lbs.
- 20/20 near vision required (corrected as acceptable).
- Must be able to recognize and distinguish among the colors red, yellow, and blue.
- Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
- No contact lenses may be worn in the work environment. No make-up, jewelry, nail polish or artificial nails may be worn in the work environment when applicable.
- In general, the position requires a combination of sedentary work, standing work, and walking around observing conditions in the facility.
- May be required to enter a cold, wet environment and climb stairs or ladders to retrieve samples.
- Will work around chemicals such as alcohol, acids, buffers and celite that may require respiratory protection.
- May be required to work or be assigned to a different shift to meet business needs. Must be willing to work off shift hours.
- Must be able to work overtime as required.
- May be required to work in a confined area.
- Primarily inside working conditions.
- Some clean room and cool/hot storage conditions.
- 5% travel as applicable.
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