BIO/PHARMA Manufacturing Supervisor-NIGHT SHIFT
Essential Functions and Responsibilities
- Develop a Subject Matter Expert (SME)-level understanding of and can execute as skillfully as well as troubleshoot GMP manufacturing process(es).
- Assists with identifying training needs, establishing a feedback loop to ensure continuous improvement.
- Deliver training sessions and ensure training documentation is maintained.
- Understand and comply with quality standards and requirements as documented. Ensure training schedules meet company production and quality targets.
- Provide operational support functions, including materials stocking and transfer, kit preparation, reagent preparation, room readiness, cleaning activities, and equipment maintenance.
- Perform document review, including executed Batch Records and Logbooks.
- Support documentation needs, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to reflect current procedures accurately.
- Execute documentation Change Controls of SOPs, Batch records, etc., as needed.
- Support interdepartmental and departmental projects in a contributor capacity.
- Supports technical transfer and additional research-level testing activities as needed.
- May work on moderately complex assignments, requiring judgment to resolve operational issues without negatively impacting manufacturing efforts.
- Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
- Completes recording of data to comply with regulatory requirements.
- Attend or hold the daily huddle meeting and escalates issues/concerns at that forum to Area Management for further investigation.
- Ability to work in a team environment and independently as required.
- Works on routine assignments per written procedures, where the ability to recognize deviation from accepted practice is required.
- Work in a cleanroom with biohazards, human blood components, and chemicals
- Must adhere to core values, policies, procedures, and business ethics.
- Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
- Perform miscellaneous duties as assigned.
Travel – 5%
Required Education, Skills, and Knowledge
- Bachelor's degree or some post-secondary education.
- Demonstrated technical knowledge of aseptic processing in cleanroom environments is a must.
- Ability to mentor and provide best practices to other team members.
- Must be able to work with ambiguity – ready to change gears and plans quickly and manage constant change.
- Must be able to read, write and understand English for Good Documentation Practices
- Proficient with computers and Microsoft (Excel, Word, Outlook) programs.
- Ability to perform arithmetic calculations accurately and reproducibly, including fractions, decimals, percentages, and basic algebraic and geometric calculations.
- Ability to build relationships quickly and credibly.
- Ability to work successfully in a fast-paced, team-oriented environment.
Salary Range: $115-130K/yr*** Based on experience
