Quality Assurance Associate
Recruiting Firm, Riderflex has been hired by our client, Scientech Laboratories, in their search for a Quality Assurance Associate.
Company: Scientech Laboratories
Industry: Research
Title: Quality Assurance Associate
Location: South Plainfield, NJ
Reports To: Quality Assurance Supervisor
Type: W-2 Full-Time
Position Summary:
The Quality Assurance Associate is responsible for reviewing laboratory processes, data, and reports of
chemical testing using established methods for OTC drugs, 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 Standard Operating Procedures (SOPs), 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 Laboratory Team to
assure compliance with SOPs and FDA cGMP standards. - Review reports for 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. - Assist 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 QA manager in Internal Audits and inspection readiness activities of external audits.
- Identify training needs for chemists in documentation to ensure compliance.
- Ensure compliance with Company’s policies and QMS requirements.
- Assist QA Team in upgrading/implementing new QMS, documentation, and change control solutions.
- Independently manages own day-to-day activities to support Lab and Quality objectives.
Requirements:
- BS in Chemistry with 3+ years of experience working in an FDA-regulated analytical chemistry laboratory.
- 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.
- Compensation $60,000 to $80,0000 (depending on experience).
- Bonus- each year for a discretionary bonus award.
- Comprehensive health benefits package. The Company covers 100% of the health benefits premium.
- 120 hours PTO and 40 hours sick days.
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 top-rated national recruiting firm, serving small to large companies globally. Our services range from C-Level Executive Search to Mass Volume Associate Level Hiring, catering to all functions and industries. We specialize in an executive recruiting process that involves vetting candidates through video interviews conducted by seasoned C-level executives.
Furthermore, we are renowned for our unique approach in finding the perfect fit for both clients and candidates. With a strong emphasis on cultural analysis and an executive recruiting process led by C-level experts, we excel in understanding and meeting specific industry needs.
Our mission is to create dynamic work environments driven by our commitment to excellence in recruiting, consulting, and candidate services. At Riderflex, we don’t just fill positions; we forge lasting relationships that propel businesses and careers forward.