Associate QA 1 (Biotechnology) 3209679
Now Hiring: QA Associate I – Biotechnology Industry
Industry: Biotechnology
Contract Partner: ProQuality Network
Location: Richmond, KY (100% Onsite) Open for locals
Position Type: Temp-to-Hire (Approx. 6 Months)
Shift: Friday – Sunday | 6:00 AM – 6:00 PM
Openings: 3
Shift Availability
Candidates must be available for all the following shifts, as the final shift assignment will be determined by the client based on operational needs:
- Friday – Sunday | 6:00 AM – 6:00 PM
- Friday – Sunday | 6:00 PM – 6:00 AM
- Monday – Friday | 6:00 AM – 2:30 PM
Summary
ProQuality Network is pleased to offer an exciting contract opportunity with our biotechnology client for a QA Associate I role. This position supports Quality Assurance operations in the manufacturing of solid oral dosage pharmaceutical products. The QA Associate will provide real-time quality oversight and ensure strict adherence to cGMP standards, FDA regulations, and internal policies and procedures.
Key Responsibilities
- Monitor manufacturing activities to ensure compliance with cGMP, FDA, and internal procedures
- Conduct real-time auditing of batch records for completeness, accuracy, and conformance to process parameters
- Recommend and review revisions to Standard Operating Procedures (SOPs) and batch records
- Perform routine testing of in-process and finished product samples, including:
- Particle size
- Bulk density
- Moisture content
- Appearance
- AQL testing
- Perform environmental monitoring through microbial swabbing of equipment and room surfaces
- Clear rooms and equipment post-cleaning in accordance with procedural requirements
- Identify and resolve real-time production errors to avoid potential deviations
- Collaborate with cross-functional teams to assess deviations and determine investigation needs
- Initiate deviation reports in TrackWise, providing detailed documentation for follow-up investigations
- Manage quality status of Work-in-Progress (WIP) and finished goods in both physical and digital inventory systems (JD Edwards)
- Support investigations by gathering data and conducting root cause analysis
- Train and coach manufacturing staff on cGMP compliance and documentation practices
- Assist in customer complaint investigations by inspecting retains and complaint samples
- Promote teamwork and maintain strong communication across departments
- Support continuous improvement initiatives and corrective/preventive actions (CAPAs)
- Carry out other quality-related tasks as assigned within the scope of the QA Associate role
Required Qualifications
- Preferred: Bachelor’s degree in a science or technical discipline, with at least 2 years of relevant work experience in a regulated manufacturing environment
- Minimum: High school diploma with 4+ years of relevant experience in a cGMP-regulated setting
- Strong working knowledge of cGMPs, SOPs, and pharmaceutical manufacturing processes
- Desired certifications: Lean Six Sigma, ASQ, or other professional quality credentials
If you're a motivated quality professional ready to grow your career in the biotechnology sector, apply now through this job description with your most updated resume to be considered!