The Production Manager’s responsibilities include: Supervision of one or more of the Production areas, which may include formulation, filling, and inspection/labeling. Find ways to improve the organization’s production processes and structures.Collaborate with other departments and team members to set goals for the production team.Overseeing implementation and compliance with STAQ Quality Systems (includes SOPs, WIs, etc.), continuous quality improvement activities, etc. Ensuring compliance with Food and Drug Administration (FDA) guidance’s.
Supervise employees who are responsible for formulation; aseptic filling; inspection and labeling; or facility sanitization. Position may have dotted line supervision to other areas of operations.Coordinate and provide training to employees in formulation, aseptic filling and applicable production processes. Provide strong people leadership with a focus on creating/maintaining a positive work environment through effective communication, performance management, accountability, etc. Conduct regular training and reviews for operations personnel.Analyze Production efficiencies, downtime, and waste. Lead teams to improve results and production output. Write or assist with writing non-conformances that occur in the department. Work with Quality to quickly resolve any variance or document errors so that product may be released on time. Oversee in-process controlled substances inventory. Supports technical teams such as engineering, facilities, etc. in their activities.Assist in managing staffing levels and budget spending when necessary.Demonstrate ability to lift a minimum of 50 pounds.
4-year accredited college degree or 5+ years of experience in a cGMP production environment; preferably a pharmaceutical cGMP environment.Minimum 5 years of general work experience.1-3 years of experience in supervision; 2 or more years aseptic processing preferred. Knowledge of cGMP guidelines/standards.
Experience with ISO Standards.Demonstrated effective and respectful interaction skills and a measurable track record of influence at all levels of an organization. Excellent organizational, leadership, motivational, analytical problem solving and strategic thinking skills. Excellent written and verbal communication skills.Strong project management skills.Ability to work in a fast-paced environment with dynamic priorities and demands.