Associate Specialist, Quality Assurance
$71,900–$113,200 year
On-siteWest Point, Pennsylvania, United States
Job Summary
Conduct quality checks of finished products including visual inspection of vials, syringes, and packages. Verify appropriate line clearance between batches to prevent product mix-ups and review GMP documents and batch records. Provide rotational support across Quality Assurance, Quality Operations, and Environmental Monitoring while participating in continuous improvement projects with Operations and Technology teams. Assist with regulatory inspections and provide quality guidance for investigations, change control, and validation activities. Work 12-hour day and night shifts rotating every 9 weeks with weekend coverage and off-schedule support opportunities.
Required Qualifications
- Bachelor's Degree in Engineering or Sciences
- Willing to work alternate shifts and weekends
- Ability to focus on and obtain results
- Good verbal and written communication skills
- Ability to effectively collaborate within and across an integrated manufacturing team
- Ability to enact conflict resolution
- Ability to effectively respond to change
- Excellent analytical and organizational skills
- High personal integrity, credibility and energy
- Flexibility to perform related tasks to support the business
- Computer literacy in MS Office, Word, Outlook, Excel
- Valid Driving License
- Ability to Coordinate
- Analytical Problem Solving
- Aseptic Filling
- cGMP Compliance
- Cleaning Equipment
- Communication
- Competency Management
- Computer Literacy
- Decision Making
- Good Manufacturing Practices (GMP)
- Leadership
- Manufacturing
- Manufacturing Documentation
- Microsoft Word
- Operational Quality
- Peer Reviewing
- Procedure Adherence
- Process Improvements
- Quality Assurance Processes
- Quality Compliance
- Quality Management Standards
- Quality Standards
- Quality Support
- Results-Oriented
Desired Qualifications
- 0-2 years working experience in cGMP pharmaceutical environment
- Experience using Lean/Six Sigma tools
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