Job Description

Immediate Need for Manufacturing Specialist position in Philadelphia, PA with a biotech company.

Needs GMP and aseptic, cell culture experience.

Essential Functions and Responsibilities

• Support documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.
• Lead teams investigating minor, major and critical non-conformances and deviations, including gathering information through structured root cause analysis. Draft and revise deviation reports as needed to assure that deviations are addressed in a timely manner.
• Own and manage change controls associated with manufacturing areas and equipment.
• Participate in technology transfer, conference calls and sharing of technical information.
• Coordination of front-end document requests with supporting departments.
• Assure that Deviations and CAPAs are addressed in a timely manner, and that Batch Records revisions are reviewed and approved in a timely manner.
• Continuously seek and support new approaches, practices, and processes to improve the efficiency and efficacy of document review and revision.
• Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
• Attends the weekly management meeting to discuss timelines and weekly priorities.
• Contribute to projects to ensure timely initiation and completion of work.
• May work on assignments that are moderately complex in nature, where judgment is required to resolve operational issues without negatively impacting manufacturing efforts.
• Troubleshoot issues and prioritize workload to solve moderately complex problems, including on the floor troubleshooting support as needed.
• Ability to work in a team environment and independently as required. Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• Ensure raw data records are accurate, complete, and in appropriate order, and meet protocol specifications and/or GMP requirements. Review data as generated/collected by less experienced technical staff.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
• Perform miscellaneous duties as assigned.

Travel

• May require up to 10% travel, based on business need.

Required Education, Skills, and Knowledge

• Minimum bachelor’s degree (B.A./B.S.) in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
• Minimum of 2 years of experience in biopharmaceutical based GMP manufacturing operations.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Demonstrated strong technical knowledge of aseptic processing in cleanroom environments is a must.
• Ability to build relationships quickly and credibly. Provide consistent, excellent support to staff, with the ability to influence large teams within the manufacturing department representing a variety of personalities and experience levels.
• Proactive, results oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment.
• Ability to deal with ambiguity – ready to change gears and plans quickly, with the need to manage constant change.
• Ability to work successfully in a fast-paced, team-oriented environment.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
• Excellent presentation skills, both written and verbal.
• Understands and complies with quality standards and requirements as documented.
• Must have strong written and verbal communication and organizational skills.
• Strong computer skills, problem solving and attention to detail.
• Familiarity with data and sample management required (LIMS/MES)
• Able to work independently with minimal supervision.
• This position is currently for regular work week hours (1st shift M-F)
• Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).

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