Find & Apply For Quality Control Analyst Jobs in Stuyvsnt Plz, New York

Senior Quality Control Data Reviewer (cGMP Analytical Laboratory) Role Overview We are seeking an analytical, meticulous, and experienced Senior Quality Control Data Reviewer to ensure the highest standards of data integrity and regulatory compliance across our analytical testing laboratories. In this role, you will conduct rigorous technical reviews of raw data generated from compendial and in-house methodologies, verify adherence to cGMP guidelines, and support critical Quality Management System (QMS) workflows. This is a vital quality assurance and compliance position for a detail-oriented professional who excels at technical data verification and cross-functional collaboration. You will partner closely with laboratory personnel, assist with raw material releases, review compliance documentation, and help mentor incoming team members. If you possess a strong scientific background in chemistry or life sciences combined with cGMP laboratory experience, we want to hear from you. Key Responsibilities Analytical Data Review & cGMP Compliance

• Data Verification:

  Perform thorough technical reviews of raw analytical data generated from diverse compendial testing (USP/NF, EP, JP) and client-specific methodologies to ensure complete accuracy and data integrity.

• SOP & Specification Adherence:

  Review quality control testing and laboratory records to verify strict compliance with internal Standard Operating Procedures (SOPs) and product specifications.

• Laboratory Collaboration:

  Partner directly with lab analysts and technical personnel to resolve testing discrepancies, clarify analytical findings, and maintain uncompromised cGMP compliance.

• Production & Raw Material Support:

  Provide regulatory and quality oversight for raw material releases, GMP production suite commissioning, and quality assurance cleaning verifications as needed. Quality Management Systems (QMS) & Training

• QMS Documentation:

  Author, review, and approve critical Quality Management System documents, including change controls, SOPs, deviations, and Corrective and Preventive Actions (CAPAs).

• Performance Reporting:

  Report evaluation metrics to laboratory management, highlighting developmental opportunities, training needs, and operational performance highlights.

• Onboarding & Training:

  Provide hands-on training and mentorship to new laboratory hires; participate in continuous education on cGMP updates, data integrity standards, and analytical techniques. Qualifications & Requirements Minimum Qualifications

•

Education:

oBachelor of Arts or Bachelor of Science (BA/BS) Degree in Chemistry, Biochemistry, or a relevant scientific field. o

Alternative:

Master of Arts or Master of Science (MA/MS) Degree in Chemistry or a related scientific discipline. •

Experience Baseline:

o3+ years of related professional work experience with a BA/BS degree. o1+ year of related professional work experience with an MA/MS degree. o

Note:

Experience must be gained within a pharmaceutical, biotechnology, medical device, or cGMP FDA-regulated laboratory environment.

• Technical Mastery:

  oComprehensive working knowledge of current Good Manufacturing Practices (cGMP) and data integrity principles. oFamiliarity with compendial testing requirements (USP, NF, EP, JP) and analytical instrumentation data. oDirect experience writing, reviewing, or managing QMS documentation (deviations, CAPAs, change controls, SOPs).

• Core Competencies:

  Exceptional attention to detail; strong analytical and problem-solving capabilities; excellent written and verbal communication skills; ability to work independently and collaboratively in a fast-paced quality control environment. Preferred Attributes
• Direct experience supporting GMP production suite commissioning or raw material release programs.
• Background in conducting QA cleaning verifications and facility inspections within regulated manufacturing settings.
• Prior experience delivering cGMP and data integrity training to laboratory personnel.

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, AllSTEM Connections 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. AllSTEM Connections 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.