The QA Supervisor is responsible for the quality aspects of batch record review, lot release, deviations and incoming inspections, change controls, complaints, SOPs, forms, and logbooks, etc.per cGMP and company standards. To supervise on the floor activities in compliance with company procedures and good documentation practices. Support documentation during GMP audits. To review and approve all QA related documentation. To perform trending and report periodic quality metrics. To interact with internal and external clients in preparation for new products (development, clinical and commercial) manufactured at the company.
The QA Supervisor in this role, not only helps to maintain quality of the documents but leads the team in decision making, department improvement projects, team management, assignments and metrics. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. The team currently consists of 6 full time employees (5 Quality Specialists and 1 Senior Quality Specialist). This role will be a working supervisor role and will contribute to the same review activities as the Quality Specialists.
- Daily management of activities related to incoming inspections and deviations (batch records, specifications, QIS, etc.)
- On the floor oversight of production and quality activities. This responsibility will include aseptic gowning and some shift work.
- Reviews and approves deviations reports, change controls, product complaints, specifications, SOPs and forms.
- Perform batch record review and lot release.
- Interact with other departments and customers to address investigations and customer questions.
- Prepare monthly and quarterly quality metric presentations.
- Review and approve cGMP documentation as related to functions of incoming QA and investigations.
- Support documentation during client audits and regulatory inspections.
- Lead and support process improvement teams within the company.
- Utilize investigative techniques to determine root causes of deviations and to determine the proper corrective and preventive actions.
- Responsible for all supervisory activities including, but not limited to, interviewing, hiring, training, coaching performance management, discipline, and termination recommendations.
- Develop, motivate, and lead direct reports towards achieving organizational goals. Conduct periodic meetings and provide timely feedback.
- Responsible for scheduling. Facilitates transitions between shifts and seamless handoffs. Communicates key information to peers, team members and production management.
- Any other tasks assigned by management.
- Bachelor's degree (BA or BS), preferably in Natural Science
- Minimum of 3 years of relevant experience in the pharmaceutical industry in a Quality Systems or Quality Assurance environment.
- Expert in Quality related electronic systems (for example, LN, QIS, LIMS)
- 1+ years of supervisory experience
- Eligible to work in the USA