Job Title: Sterile Manufacturing Quality Specialist (Candidates with Bachelor's Degree will be considered)
Location: Durham, NC (Onsite)
Duration: 12 Months
Pay Rate: $55.00/hr (W2)
Note: X-Ray Test and TB Test are required prior to start.
Must Have: Bachelor’s degree in Biology, Microbiology, Chemistry, Pharmacy, Chemical Engineering, or a related field.
A leading pharmaceutical facility in Durham, NC is seeking an experienced Sterile Manufacturing Quality Specialist to provide quality oversight and support for equipment qualification, documentation, and process compliance in a sterile manufacturing environment. This is a highly collaborative, detail-oriented role requiring a strong understanding of regulatory expectations, validation lifecycle, and aseptic manufacturing practices.
Provide quality assurance support and review for commissioning and qualification (C&Q) documentation including URS, FAT, IQ, OQ, PQ.
Ensure equipment qualification activities align with cGMP, regulatory guidelines, and internal Quality Management Systems.
Support and review GMP documents such as Quality Agreements, Risk Assessments, Change Controls, Batch Records, SOPs, and validation protocols.
Provide input into facility readiness efforts for regulatory inspections, including Pre-Approval Inspection (PAI) preparation.
Oversee qualification and compliance of various sterile manufacturing equipment (e.g., isolators, RABS, lyophilizers, autoclaves, incubators, formulation vessels).
Collaborate with operations, validation, and engineering teams to ensure timely execution and approval of required documentation.
Manage multiple projects simultaneously while ensuring high attention to detail and effective team communication.
Bachelor’s degree in Biology, Microbiology, Chemistry, Pharmacy, Chemical Engineering, or a related field.
Minimum 5 years of experience in the pharmaceutical industry, specifically in sterile manufacturing environments.
At least 3 years of hands-on experience in equipment and utilities qualification (URS, FAT, IQ, OQ, PQ).
Strong knowledge of regulatory standards (FDA, EU, ICH) for sterile product manufacturing and validation practices.
Demonstrated experience with technical document review, batch record oversight, and regulatory compliance preparation.
Excellent communication, collaboration, and documentation skills; strong ability to build relationships across cross-functional teams.
Top Skills for Success:
Detail-oriented approach with strong document management capabilities
Expertise in equipment qualification and sterile manufacturing QA
Strong interpersonal skills and ability to work in a collaborative team environment