Lead Associate, Quality Operations

Company: Disability Solutions
Location: Princeton
Posted on: November 19, 2023

Job Description:

At Dr. Reddy's "Good Health Can't Wait" By joining Dr. Reddy's, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community.Diversity, Equity & Inclusion At Dr. Reddy's, we are deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team. We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background. Purpose: The Lead associate will play a pivotal role in maintaining and enhancing the quality and safety of our dietary supplement products. This individual will be responsible for developing, implementing, and overseeing quality assurance and control processes to ensure that our products meet regulatory requirements and exceed customer expectations. Responsibilities:

• Develop, implement, and manage the company's quality assurance systems, including Standard Operating Procedures (SOPs), quality control protocols, and documentation to ensure compliance with FDA regulations and industry standards.
• Establish and maintain rigorous product quality control standards, including ingredient verification, batch testing, and product release processes.
• Oversee the entire batch release process, ensuring that all dietary supplement batches are thoroughly evaluated before release to the market.
• Conduct detailed reviews of batch records, certificates of analysis, and related documentation to confirm compliance with established quality standards and specifications.
• Make informed decisions regarding the release or rejection of product batches based on test results, quality criteria, and regulatory compliance.
• Stay up to date with dietary supplement regulations, including FDA guidelines, and ensure the company's compliance with all relevant laws and regulations.
• Collaborate with external partners to establish quality requirements, conduct audits.
• Oversee and manage product testing, including stability studies, shelf-life assessments, and analytical testing to ensure product safety, purity, and potency.
• Provide support in addressing Non conformances, deviations and OOS/OOT investigations, customer complaints and feedback related to product quality and safety.
• Provide training and guidance to employees on quality assurance practices, procedures, and compliance requirements.
• Continuously assess and improve quality assurance processes to enhance product quality, reduce costs, and increase operational efficiency. Qualifications/Skills:
  • Bachelor's degree in a relevant field (e.g., Chemistry, Biology, Food Science, or related disciplines). Master's degree preferred.
  • Minimum of 5 years of experience in quality assurance and regulatory compliance in the dietary supplements industry.
  • In-depth knowledge of FDA regulations, specifically with 21 CFR 111, GMPs, and other relevant quality standards.
  • Strong analytical and problem-solving skills.
  • Excellent communication and leadership abilities.
  • Proficiency in quality management software and Microsoft Office Suite.
  • Attention to detail and commitment to ensuring product safety and efficacy. Must be a U.S. citizen or lawful permanent resident of U.S. or otherwise authorized to work in the U.S. without requiring sponsorship now or in the future. Equal Opportunity Employer: An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Keywords: Disability Solutions, Trenton , Lead Associate, Quality Operations, Other , Princeton, New Jersey