Job Summary:

• 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 (including SOPs, WIs, etc.), continuous quality improvement activities.
• Ensuring compliance with Food and Drug Administration (FDA) guidance’s

Responsibilities: 

• 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.
   
   

Required Skills/Abilities:

• 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.

Education and Experience:

• 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.
• 2+ years of experience in supervision; 2+ years aseptic processing preferred.
• Knowledge of cGMP guidelines/standards.

Physical Requirements: 

Prolonged periods of sitting at a desk and working on a computer.

Must be able to lift up to 15 pounds at times.