This position is responsible for the direct supervision of Quality Assurance Inspectors performing incoming and distribution inspections in order to assure compliance with CGMP’s and company SOP’s within the Supply Chain area.
- Applies Good Manufacturing Principles (cGMP) in all areas of responsibility.
- Demonstrates and promotes the company vision..
- Conducts all activities in a safe and efficient manner.
- Schedules QA personnel performing incoming/distribution inspections.
- Instructs QA personnel in appropriate inspection procedures and techniques.
- Reviews and revises quality-related Supply Chain procedures and documentation.
- Provides leadership in promoting and enforcing company quality requirements.
- Develops and directs Quality Assurance systems that will enhance and maintain products that meet quality specifications and standards.
- Evaluates and develops techniques designed to maintain awareness of SOP’s, CGMPS’s and clinical requirements.
- Assures that issues potentially affecting product quality/compliance are escalated to the attention of Management.
- Assures that issues are resolved in a timely manner and corrective actions are implemented accordingly.
- Leads and successfully completes QA training sessions for CGMP’s, SOP’s, quality, etc.
- Provides positive and critical feedback to employees related to job performance.
- Completes the performance evaluation of QA Inspectors including the identification of development needs.
- Assures maintenance of quality aspects of the warehouse including quarantine, staging and reject areas.
- Assures that inventory system status changes are completed accurately and completely.
- Other duties may be assigned to meet business needs.
- Associate’s degree required. Bachelor’s degree preferred.
- A minimum of 2 years of experience in the Pharmaceutical of related regulated industry
- Experience with Quality Systems (QA Control, Inspection, Auditing, Deviation Investigations)
- This position is responsible for the direct supervision of QA Inspectors on the shift.
- Requires excellent supervisory skills and leadership ability. Must be comfortable with decision-making on quality issues. Requires ability to multi-task and prioritize.
- ASQ/CQA or equivalent experience/credentialing preferred.
- Experience interfacing with Regulatory bodies- FDA/ISO and auditing.
- This position is responsible for the direct supervision of the QA Inspectors on the shift.
- To perform this job successfully the individual must be experienced with QA procedures in a pharmaceutical environment with emphasis on documentation.
- Must have extensive familiarity with packaging paperwork and a sound understanding of CGMP’s and SOP’s.
- High ethical standards required to uphold compliance.
- Thorough knowledge of Current Good Manufacturing Practices and SOP’s.
- Requires knowledge of clinical packaging operations and leadership ability.
- Must be comfortable with decision-making on diversified issues and communicating directly with customers on a routine basis.
- Organizational skills are required in order to quickly retrieve needed documents
- Extensive standing and walking on packaging floor in order to monitor room activities.
- Work schedule, Monday through Friday, 8 hours per day. Additional overtime and weekend (Saturday or Sunday) work may be required.
- The employee must occasionally lift and or move up to 20 pounds.