Quality Assurance Technician
2 weeks ago
Job Summary
This position provides Quality Assurance support for Lincoln manufacturing operations, supporting shared time between the B1 Virus Production and Biological Process Manufacturing (BPM) manufacturing process teams.
Responsibilities
- Perform routine batch record review functions for assigned support areas within established timelines, ensuring compliance with all applicable regulatory requirements and product registrations.
- Track reviews and releases to support metrics for functional QA area.
- Work with QA Operations Compliance Specialists to complete and document manufacturing area process checks and audits.
- Other responsibilities as assigned.
Requirements
- High school diploma or equivalent required with at least 4 years of relevant experience.
- Associate degree with minimum 3-5 years of progressive experience at the OTE Lead level or above, in Manufacturing or Quality Operations.
Skills and Competencies
- Strong written and oral communication and ability to work effectively on a team.
- Process and detail oriented with the ability to follow processes.
- Demonstrated organizational, administrative skills, in addition to proven skills in multi-tasking and prioritizing projects in support of standard work.
- Ability to communicate effectively with Team Members to facilitate completion requests and review from all levels to meet all deadlines.
Preferred Qualifications
- Demonstrated knowledge and experience with SAP.
- Self-directed – can work with little or no supervision on most tasks.
- Experience in manufacturing operations, quality operations, and/or regulatory affairs.
- Previous experience with batch record reviews.
- Ability to develop solutions to routine problems following procedures.
Physical Position Requirements
- Lift materials up to 40lbs.
- Ability to sit, stand and walk.
- Occasional overtime work may be needed.
- Must wear appropriate PPE (Personal Protective Equipment) in manufacturing/packaging areas.
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