Lead Associate, Quality Operations
Company: Disability Solutions
Posted on: November 19, 2023
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.
- 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
- 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
- Bachelor's degree in a relevant field (e.g., Chemistry,
Biology, Food Science, or related disciplines). Master's degree
- 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
- 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
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