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, CAPA's etc), SOP's, QA investigations & reports, CAPA's 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 cGMP's
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