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Pharma - Quality Specialist
Contract: West Point, Pennsylvania, US
Salary Range: 34.00 - 39.00 | Per Hour
Job Code: 359399
End Date: 2025-03-29
Job Status: Expired
This Job is no longer accepting applications
About the Role:
We are seeking a Quality Specialist to provide direct Quality support to a production area as part of a Quality IPT (Integrated Product Team). The Quality Specialist will ensure the quality and compliance of products manufactured by the functional area and adherence to Good Manufacturing and Documentation Practices.
Responsibilities:
- Fully trained in relevant Standard Operating Procedures (SOPs), Work Instructions (WIs), and competency-based activities.
- Learn cGMPs, the manufacturing process, and company quality systems.
- Provide presence on the shop floor to support compliance and data integrity.
- Review production documentation (batch records, logbooks) for accuracy and compliance with cGMPs and company procedures.
- Review and approve new and updated SOPs and Controlled Job Aids.
- Actively participate in the Tier process to address concerns and collaborate on resolutions.
- Foster a customer service attitude within the functional area.
Education Qualification:
- Bachelor’s degree in a scientific or engineering field (preferred).
- Candidates with degrees in other fields will be considered if accompanied by significant relevant experience.
Required Skills:
- 1-2 years of relevant post-degree work experience in a GMP Manufacturing or Laboratory environment.
- Strong oral and written communication skills.
- Familiarity with GMP documentation review.
- Understanding of cGMPs and regulatory requirements in the pharmaceutical field.
- Demonstrated interpersonal skills and ability to work in a team environment.
Preferred Experience and Skills:
- Experience in quality systems and authoring GMP documents.
- Experience with gowning.
- Strong analytical aptitude, critical thinking, and problem-solving skills.
Compensation
- Pay Range: $34 - $39 per hour
Job Requirement
- Quality Specialist
- Pharma
- Pharmaceutical
- Aseptic gowning
- Aseptic
- GMP
- Laboratory
- cGMPs
- scientific
- SOPs
- Standard Operating Procedures
- batch records
- logbooks
- Documentation
Reach Out to a Recruiter
- Recruiter
- Phone
- Rohan Lazarus
- rohan.lazarus@collabera.com
This Job is no longer accepting applications
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