Quality Assurance Supervisor

Recruiting Firm, Riderflex has been hired by our client, Scientech Laboratories, in their search for a Quality Assurance Supervisor.
Company: Scientech Laboratories
Industry: Research
Title:Quality Assurance Supervisor
Location: South Plainfield, NJ
Reports To: Laboratory Director
Type: W-2 Full-Time
Salary: $80k-$100k plus bonus
Position Summary:
The Quality Assurance Supervisor is responsible for building and reviewing Quality Assurance and
laboratory work processes. The QA Supervisor is also responsible for reviewing data and reports of
chemical testing using established methods for Cer, cosmetics, dietary supplements, and Rx drug
products in an FDA cGMP environment for various clients.
Primary Responsibilities:

• Review analytical raw data to ensure conformance to specifications and ensure documentation in
  compliance with cGMP regulations and FDA guidelines.
• Issue Certificate of Analysis after full review of analytical raw data.
• Critically review and release data packages and technical reports produced by the Laboratory Team to ensure compliance with SOPs and FDA cGMP standards.
• Review Method Validation, Method Verification, raw data of API, raw materials, and finished products.
• Ensure Standard Operating Procedures (SOPs) and all method documentation is up to date and
  compliant per FDA cGMP/GLP requirements.
• Collaborate with Lab Team and Client Relations to investigate, troubleshoot, and resolve out-of
  specification (OOS) results.
• Review equipment/instrument logbooks to ensure accuracy and completeness.
• Assure all documentation (hard copy and digital) is complete, compliant, and of adequate quality to
  withstand FDA audit.
• Assist Lab Director in Internal Audits and inspection readiness activities of external audits.
• Identify training needs for chemists in documentation to ensure compliance.
• Ensure compliance with the Company's policies and QMS requirements.
• Assist the QA Team in upgrading/implementing new QMS, documentation, and change control solutions.
• Independently manages Quality Team day-to-day activities to support Lab objectives.

Requirements:

• BS in Life Sciences (Chemistry preferred) with 5-10 years of experience working in the Quality Program of an FDA-regulated analytical laboratory.
• Minimum 2-3 years experience in leadership and management roles.
• Experience in building a Quality Assurance program, documentation, and work processes.
• A strong understanding of cGMP/GLP requirements and QA procedures for an analytical laboratory.
• Experienced with reviewing raw data, Lab data packages, reports, and SOPs.
• Experience in OOS investigations to identify root cause analysis.
• Experience in Change control and writing Deviation reports.
• Solid understanding of a variety of analytical chemistry analyses such as LC, GC, IR, UV, dissolution, viscosity, melting point, and others.
• Experience with the analysis and GMP reporting process of OTC drugs, cosmetics, dietary supplements, and/or botanical products.
• Strong technical writing skills.
• Independent, yet a great team player.
• Organized and able to plan work efficiently and effectively.
• Ability to consistently deliver on-time results for clients.

Benefits:

• Health Benefits
• Vision
• Dental

About Scientech Laboratories:
Scientech is an analytical testing laboratory with over 36 years of industry experience. They provide a comprehensive range of analytical laboratory services to the pharmaceutical, nutraceutical, and cosmetic industries.
Scientech's mission is to be the complete solution for the biopharmaceutical industry's Analytical Testing and Research and Development needs. The Team at Scientech prides itself on staying informed and ahead of the changing regulatory landscape. They pledge to serve their clients by providing them with accurate results, in an expeditious manner, with competitive pricing for their formulation, testing, and research and development needs.
About Recruiting Firm, Riderflex
Riderflex is a national, Colorado-based, premier headhunter, RPO, and employment agency; recruiting and searching for the top talent for staffing your teams.
Our core purpose is to help create dynamic work environments for clients and candidates. We specialize in three core competencies; recruiting, consulting, and candidate services. Our recruiting process includes vetting candidates through video interviews with current C-Level executives with over 30 years of experience. We recruit for all industries and functions, from the C-Suite to Manager level, nationwide. Riderflex brings your leadership to the next level with consulting services, including Human Resources, Marketing, IT, Sales, Finance, and Operations.
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