Manufacturing Quality Supervisor
Manufacturing Quality Supervisor manages quality assurance personnel and activities associated with production processes through manufacturing and packaging. Directly manages reports that conduct Manufacturing Quality (AQL) sampling and auditing of primary and secondary packaging. Oversees, various tasks and training related to general sampling and ANSI sampling. Reviews and approves procedures and documents relating the auditing of manufacturing and the training of sampling colleagues. Leads a diverse team of individuals. Works interdepartmentally with visual inspection, pack, validations, and other site departments. Reviews batch record documentation. Monitors and reacts to the Cold Storage Monitoring System. Initiates investigations, corrective and preventative actions when required. Insures GMP compliance of the sampling program. Maintains QA databases for QA activities.
- Supervises quality assurance personnel and activities associated with production processes through manufacturing and packaging.
- Leads a tiered meeting system that allows shift by shift reporting, generating metrics and improvement initiatives.
- Utilizes Quality concepts to identify needed improvements in process and product quality.
- Evaluates deviation and complaint data for undesirable trends. Writes reports and makes recommendations based on these evaluations.
- Assures GMP compliance for testing facilities, equipment and procedures.
- Subject Matter Expert in quality sampling and auditing for Operations and Planning.
- Participates in the investigation and action taken for deviations. Manages timely completion of investigations to support production operations. Maintains QA databases for QA activities. Writes and supports departmental investigations.
- Monitors and operates computer systems for the monitoring of cold storage areas.
- BA/BS required (science degree preferred)
- Minimum of 1 year of related industry experience or demonstrated proficiency and understanding of the pharmaceutical industry.
- 0-3 years of supervisory experience
- Minimum of 1 year of related industry experience or demonstrated proficiency and understanding of the pharmaceutical industry. 0-3 years of supervisory experience. Experience in sterile manufacturing and an understanding of the sterilization process and its impact to products
- Requires good written and verbal communication skills.
- Requires tactful, persuasive, and assertive human relations skills.
- Ability to manage, organize, problem solve and manage multiple priorities in a fast pace environment, while exercising leadership, diplomacy, and problem-solving skills, coordinating and working with all levels of Colleagues.
- Previous experience in GMP investigations, or QTS.
- Previous experience in sterile manufacturing
- Understanding of Basic Statistical methodologies
- PROBLEM SOLVING: Must provide direction to production when problems occur in the manufacturing environment.
- AUTHORITY TO ACT: Indirectly responsible for the quality of the product that is produced in this facility. Decisions are made based on knowledge and experience, with input from the manager and/or QA Director as required.
- AUTHORITY TO ACT: as the responsible person for in decision making regarding Manufacturing Quality sampling and auditing of product in all stages of manufacturing.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Position may require some weekend and off shift presence as business needs dictate.
Other Job Details:
- Last Date to Apply for Job: August3rd 2021
- Eligible for Relocation Assistance: No
- Eligible for Employee Referral Bonus: YES