Manufacturing Specialist
1 month ago
Salary: $60-90k depending on experienceResponsibilities:
- Collaborate with internal and external customers to prioritize GMP document review schedule
- Coordinate scheduling of formulation in-process sample testing with cross-functional organizations to ensure timely receipt of results for formulation release
- Facilitate submission of reviewed formulation BPRs with Quality Assurance and coordinate release of formulations for production use
- Facilitate and coordinate submission of reviewed operation BPRs with Quality Assurance to ensure lot disposition and release timelines are maintained
- Perform real-time review of in-progress formulation and operation BPRs within the GMP production suites
- Must be able to fully gown into ISO 8 (Class 100K) and ISO 7 (Class 10K) GMP production suites to perform real-time review of BPRs
- A Bachelor's degree in life sciences or engineering is required.
- Biopharmaceutical experience is required – may possess 3 to 5 years technical experience in industry or in graduate level studies.
- Experience working for a contract manufacturing organization in the life sciences field is preferred.
- Proficient in personal computer skills, including e-mail, record keeping, routine database activity, word processing, spreadsheets, and graphics.
- Ability to prioritize multiple tasks and projects simultaneously.
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
- Ability to write routine reports and correspondence.
- Ability to speak effectively before groups of customers or employees of organization.
- The successful incumbent is meticulous and detail oriented.
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QC Specialist
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