QA & QC Investigator

This QA & QC Investigator Position Features:

Location:

Rensselaer, NY 12144 ??

Pay Rate:

$30-35/hr

Duration:

3 Months Position Overview We are seeking Quality Control Analyst I professionals to support laboratory investigations, deviation handling, and compliance activities in a pharmaceutical GMP environment. This role will focus on executing and supporting QC investigations, ensuring data integrity, and maintaining compliance with regulatory and quality standards. Key Responsibilities Perform laboratory-based investigations related to QC deviations and out-of-specification (OOS) results Conduct initial impact assessments and support full investigation lifecycle Apply root cause analysis tools (e.g., Fishbone, 5 Whys) to identify true root causes Document investigations in compliance with: GMP (Good Manufacturing Practices) GDP (Good Documentation Practices) Internal SOPs and regulatory standards Support CAPA development and implementation to prevent recurrence Ensure timely initiation and closure of investigations within defined timelines Collaborate with cross-functional teams (QA, Manufacturing, etc.) Assist in backlog reduction efforts by managing ongoing and aged investigations Maintain accurate and audit-ready documentation Identify opportunities for improvements in: Analytical methods Equipment reliability Laboratory processes Participate in audits and customer interactions as needed Qualifications Bachelor's degree in Chemistry or related scientific discipline Minimum 6+ years of experience in a QC laboratory or equivalent combination of education and experience Prior experience in pharmaceutical or regulated industry (required) Strong knowledge of:

GMP & GDP

standards Deviation investigations & OOS handling CAPA processes Proven experience in technical writing and documentation Preferred Skills Experience with investigation tracking systems Familiarity with FDA regulations Strong analytical and problem-solving skills Ability to manage multiple priorities in a fast-paced environment Key Success Factors Strong attention to detail and compliance Ability to identify true root cause vs. symptoms Effective communication and cross-functional collaboration Ability to work under tight timelines Notes for Suppliers Must have hands-on QC investigation experience (not just theoretical) Pharma/GMP experience is mandatory Candidates with root cause analysis + CAPA exposure will be prioritized Short-term contract - candidates should be available for the full duration Equal Opportunity Employer / Disabled / Protected Veterans The Know Your Rights poster is available here: https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12.pdf The pay transparency policy is available here: https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf For temporary assignments lasting 13 weeks or longer, AppleOne is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required. We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team. AppleOne participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program.

https:

//e-verify.uscis.gov/web/media/resourcesContents/E-Verify_Participation_Poster_ES.pdf We also consider for employment qualified applicants regardless of criminal histories, consistent with legal requirements, including, if applicable, the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records, including, if applicable, the San Francisco Fair Chance Ordinance. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.