Quality Assurance Specialist II

2 weeks ago

South Plainfield, New Jersey, United States Riderflex Full time
Job Overview

Riderflex, a premier recruiting firm, is collaborating with Scientech Laboratories to identify a qualified Quality Assurance Associate II.

Company: Scientech Laboratories
Industry: Analytical Testing
Title: Quality Assurance Associate II
Location: South Plainfield, NJ
Reports To: Quality Assurance Supervisor
Employment Type: W-2 Full-Time

Position Overview:

The Quality Assurance Associate II plays a critical role in evaluating laboratory operations, data, and reports pertaining to chemical testing. This position operates within an FDA cGMP framework, ensuring compliance for a variety of products including OTC drugs, cosmetics, dietary supplements, and prescription medications.

Key Responsibilities:

  • Thoroughly assess and authorize data packages and technical reports generated by the Laboratory Team to ensure adherence to SOPs and FDA cGMP regulations.
  • Guarantee compliance with the organization's policies and Quality Management System (QMS) standards.
  • Maintain up-to-date Standard Operating Procedures (SOPs) and all relevant documentation in line with FDA cGMP/GLP requirements.
  • Work collaboratively with the Laboratory Team and Client Relations to investigate and resolve out-of-specification (OOS) results.
  • Ensure all documentation, both physical and digital, is complete, compliant, and of sufficient quality to withstand FDA audits.
  • Support the QA Team in enhancing and implementing new solutions for QMS, documentation, and change control processes.
  • Independently manage daily activities to align with laboratory and quality objectives.

Qualifications:

  • Bachelor's degree in Chemistry with a minimum of 3 years of experience in an FDA-regulated analytical chemistry laboratory.
  • In-depth knowledge of cGMP/GLP standards and quality assurance protocols for analytical laboratories.
  • Proficient in reviewing and drafting laboratory data packages, reports, and SOPs.
  • Strong familiarity with various analytical chemistry techniques such as LC, GC, IR, UV, dissolution, viscosity, and melting point.
  • Experience in the analysis and GMP reporting of OTC drugs, cosmetics, dietary supplements, and/or botanical products.
  • Excellent technical writing abilities.
  • Self-sufficient yet an effective team collaborator.
  • Organized with the capability to plan work efficiently.
  • Ability to consistently deliver timely results for clients.
Benefits:
  • Compensation: $60,000 to $80,000 (based on experience).
  • Annual discretionary bonus opportunity.
  • Comprehensive health benefits package, with the company covering 100% of the premium.
  • 120 hours of paid time off and 40 hours of sick leave.
About Scientech Laboratories:
Scientech is a well-established analytical testing laboratory with over 36 years of experience, offering a wide range of services to the pharmaceutical, nutraceutical, and cosmetic sectors. Their mission is to provide complete solutions for the analytical testing and research needs of the biopharmaceutical industry, ensuring accurate results delivered promptly and at competitive prices.

About Riderflex:
Riderflex is a highly regarded national recruiting firm that caters to companies of all sizes across the globe. Our services span from executive search to mass-volume hiring, tailored to various functions and industries. We pride ourselves on our unique approach to recruiting, emphasizing cultural fit and utilizing C-level executives in the vetting process to ensure the best matches for our clients and candidates.

By applying for this position, you consent to receive future communications from Riderflex regarding open positions and other relevant updates.

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