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Quality Manager
3 weeks ago
Responsibilities:
- Provide on-sight management supervision of QC and QA functions for BRH in Middletown, CT
- Ensure full control of QA core documents (i.e., MMR, BPRs, CAPAs etc), SOPs, QA investigations & reports, CAPAs and implement activities with the QC and production teams
- Ensure processes and practices in and by functional teams at the manufacturing facility as well as offsite warehouses are reflective of SOPs and cGMP requirements, including:
o Process and disposition product returns in a timely manner
o Environmental monitoring of production facility
o In-Process monitoring and performance of Quality Verifications during Production runs
o Issue deviations and conduct material reviews
- Active collaborator with the production team providing positive leadership cross functionally
- Provide complex data analysis in support of customer requests. Responsible for data collection to identify baselines and process measures, management of report distribution on a regular basis and continuously recommends changes based on identified best practice. Turns data into information and proactively identifies opportunities based on that information.
- Ensure implementation of QC processes, deliverables and system-wide analytics and support for the organization around improvement initiatives, process improvement and data mining
- o Approval/rejection of all raw materials, packaging materials, finished products, GMP-related documents, labels, forms, laboratory test results, and material specifications
- Responsible for following standard operating procedures and related systems that ensure company cGMP compliance and applicable regulations.
- Performs all functions necessary as required by management to complete the job
Required Knowledge/Skills/Experience:
- BS, or MS in Chemistry, Biology, Nutrition, or related science
- Minimum 6-8 years experience in FDA regulated Quality Control environment including QA documents for manufacturing (Master Manufacturing Records (MMR) and Batch production Records (BPRs) and reviewing deviations)
- Dietary Supplements or Food industry experience preferred
- Thorough understanding of manufacturing and production
- Significant knowledge and training in cGMPs
- Ability to work and ensure compliance in a GMP environment
- Strong leadership and team management skills, with the ability to inspire and motivate teams to achieve results
- Impeccable attention to detail
- Excellent analytical, problem-solving, and decision-making abilities
- Superior time management skills and initiative; ability to prioritize, organize, and complete projects and tasks by deadlines
- Effective communication skills, both verbal and written, able to collaborate with cross-functional teams
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