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Company Contact Info
1602 Main Street
East Hartford, CT 06108
- Taniesha Mendez
- Phone: 860-569-5970
- Phone:: 860-569-5975
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Hamilton Connections • East Hartford, CT
Posted 5 days ago
Experience - Up to 3 year(s)
Degree - 4 Year Degree
$0.00 - $75,000.00 /Year
QA - Quality Control
- Plans, coordinates, implements and directs a quality control program designed to ensure continuous production consistent with 21 CFR 111.
- Supervise, train and evaluate the Quality Control staff
- Develops and analyzes data and product specifications to determine present standards and establish proposed quality and reliability of the finished product.
- Releases finished product to distribution.
- Review batch records daily.
- Coordination of all quality control records and fillings.
- Help develop training for all employees in cGMP principles and corporate compliance requirements
- Insure quality standards set forth in SOP and cGMP.
- Write SOPs and work instructions
- Work with managers and teams to assess and ensure compliance with cGMP and company compliance plan against internal (policy/procedure) and external (contract/program) requirements; report regularly on results
- Respond to, research and provide corrective actions to customer complaints regarding quality.
- Interact with, and provide quality control guidance to, the production workforce.
- Actively participate in FDA, GMP and other inspections and audits including required responses, follow up and corrective action documentation and implementation.
- Conducts routine safety audits and training.
- Other tasks as might be assigned
- Strive for continuous improvement and participate in developing solutions to drive overall operational effectiveness including increase throughput, reduce movement/motion, waiting & transportation
- Is responsible to scheduling intercompany trucking as needed.
- Any other duties as they are needed and assigned.
- Bachelor’s Degree in appropriate discipline.
- 3 + years’ experience with a Quality Team in the Dietary Supplement, Pharmaceutical, or closely related industry.
- Significant experience and knowledge of cGMP and FDA regulations under 21 CFR 111.
- Ability to analyze records with a high level of accuracy.
- Highly developed organizational, interpersonal and management skills
- Working knowledge of current FDA Quality Systems Regulations
- Ability to work independently and resolve issues.
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