Manufacturing Quality Assurance Specialist
4 weeks ago
At CONTRACT PHARMACAL CORP, we are seeking a highly skilled Manufacturing Quality Assurance Specialist to join our team. This role is responsible for ensuring product quality is maintained through all phases of manufacturing in accordance with current good manufacturing practices.
Key Responsibilities:
- Perform in-process monitoring of all manufacturing operations, including weight, thickness, hardness, disintegration, friability, and other relevant parameters.
- Collect in-process and finished product samples as required, and support the collection of microbiological samples per procedure.
- Perform room inspections and clearances as needed, and ensure that all documentation is accurate and complete.
- Support the release of batch records, and perform AQL sampling and inspections as required.
- Identify and report any non-conformances or discrepancies to management, and review general SOPs to ensure compliance.
- Assist in employee training and support environmental monitoring activities, including water and air sampling.
- Provide additional QA technical support to the Coating Department, and review batch record documentation.
- Issue QMS forms as required, and perform daily scale weight verification.
- Maintain QA supplies, and review and approve weekly pest control logs.
- Sample transmittal to QC and Account Services, and review grounds logbook for Maintenance.
- Perform monthly audits of facility fire extinguishers, and other responsibilities as assigned by Senior Management.
Requirements:
- High School or GED diploma required, and knowledge of good manufacturing practices and good documentation practices preferred.
- Ability to read, write, and communicate effectively, and self-motivated with the ability to work in a fast-paced environment.
- Excellent organizational skills with the ability to focus on details, and physical demands include reaching, handling, and lifting up to 50 pounds.
Work Environment:
- Work environment in production operations facilities includes close proximity to heavy machinery with loud noises and pharmaceutical powders (dust).
- Potential to move between production operations sites/areas to complete job functions, and employee work hours/schedule and/or shift are subject to change based on business needs.
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