QC Investigation Specialist

Astrix • Full-time • Rensselaer, NY, US • 1d ago

Pay Rate Low: 36 | Pay Rate High: 54

Quality Control Investigation Specialist

📍 Albany, NY

🕒 1st Shift | Monday – Friday | 8:00 AM – 5:00 PM

💲 Pay Range: $36–54/hour

Terms: 3+ month contract (high probability of extension)

Position Summary

We are seeking a detail-oriented Quality Control Investigation Specialist to support laboratory investigations within a cGMP-regulated pharmaceutical manufacturing environment. This individual will partner closely with Quality Control and cross-functional teams to lead and support complex laboratory investigations, drive root cause analysis efforts, and ensure timely completion of investigations in compliance with regulatory and quality standards.

The ideal candidate will have experience conducting OOS investigations, identifying corrective and preventive actions (CAPAs), and collaborating across departments to support quality and customer commitments.

Key Responsibilities

Lead and support Quality Control laboratory investigations, ensuring timely initiation, execution, and closure in accordance with established deadlines and quality requirements.
Conduct and document investigations related to Out-of-Specification (OOS) results, laboratory deviations, and other quality events in compliance with cGMP regulations and internal procedures.
Partner with cross-functional teams and external customers as needed to support investigation activities and meet quality agreement commitments.
Perform root cause analysis utilizing tools such as 5 Whys, Fishbone Diagrams, and 6M methodologies to identify effective corrective and preventive actions (CAPAs).
Ensure initial impact assessments and investigation documentation are completed and submitted for Quality Assurance review within required timelines.
Drive investigations to closure while maintaining clear communication with management and cross-functional stakeholders regarding status updates and outcomes.
Monitor and maintain laboratory investigation metrics including analyst error trends, equipment failure rates, and test method performance to identify continuous improvement opportunities.
Support development and implementation of CAPAs and training improvements aimed at reducing recurring laboratory errors and compliance risks.
Develop standardized investigation templates and documentation practices to improve consistency and efficiency across investigation processes.
Ensure all investigation activities are conducted in full compliance with cGMP regulations, company SOPs, and global quality standards.
Serve as a primary investigator for critical laboratory-related investigations while working independently and collaboratively with the QC team.

Qualifications

Bachelor’s degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, or related scientific discipline preferred.
Experience within a pharmaceutical, biotechnology, or other cGMP-regulated laboratory environment.
Prior experience conducting laboratory investigations, OOS investigations, deviations, and CAPA activities strongly preferred.
Strong understanding of cGMP regulations, quality systems, and root cause analysis methodologies.
Excellent written documentation, organizational, and communication skills.
Ability to manage multiple priorities and meet strict investigation timelines in a fast-paced environment.
Experience collaborating with cross-functional teams and supporting audit or customer-related activities preferred.

INDBH