Assistant Production Manager

STAQ Pharma; Columbus (OH); On-site; USD 65,000 - 90,000; Full time

Job summary

A leading pharmaceutical company in Columbus, OH, is hiring an Assistant Production Manager to oversee and improve cGMP manufacturing processes. The role requires strong leadership, compliance knowledge, and the ability to work in a fast-paced environment. This position involves managing production staff, ensuring adherence to regulations, and enhancing operational efficiencies.

Qualifications

• Minimum of 5 years of leadership/management experience, preferably in a cGMP environment.
• Knowledge of cGMP guidelines/standards essential.

Responsibilities

• Direct and manage activities related to cGMP manufacturing.
• Provide leadership support and training to production staff.
• Oversee compliance with quality systems and FDA guidelines.

Skills

Leadership

Analytical problem solving

Strategic thinking

Communication

Education

4-year accredited college degree

10+ years of experience in a cGMP production environment

Job description

STAQ Pharma is currently hiring for an Assistant Production Manager to join our team in Columbus, OH.

Schedule: 10 AM to 6 PM or 12 PM to 8 PM, Monday to Friday

Summary:

The Assistant Production Manager’s responsibilities include:

• Direct and manage the respective activities related to cGMP manufacturing, including the development and implementation of manufacturing methods, processes, and operations for manufactured pharmaceutical products.
• Provide leadership support of one or more of the Production areas, which may include formulation, filling, and inspection/labeling.
• Improve the organization’s production processes and structures.
• Collaborate with other departments and team members to set goals for the production team and increase production output.
• 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.

Roles and Responsibilities:

• Provide leadership support to the Assistant Manager, Production Supervisors and Leads. Assist informulation; aseptic filling; inspection and labeling; or facility sanitization when necessary.
• Coordinate and provide training to employees in formulation, aseptic filling and applicable production processes when necessary.
• Providestrong people leadership with a focus on creating/maintaining a positive work environment through effective communication, performance management, accountability, etc.
• Provide on-the-floor support to production personnel.
• Create training curriculum 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.
• Manage the technical deviation investigation process and CAPA effectiveness. Ensure appropriate root cause and product impact assessments are completed and effective corrective/preventative actions are implemented.
• Oversee in-process controlled substances inventory.
• Supports technical teams such as engineering, facilities, etc. in their activities.
• Serve as SME as required during regulatory inspections for production documentation and processes.
• Manage staffing levels and budget spending.
• Demonstrate ability to lift a minimum of 50 pounds.

QUALIFICATIONS:

• 4-year accredited college degree or 10+ years of experience in a cGMP production environment; preferably a pharmaceutical cGMP environment.
• Minimum of 5 years of leadership/manager experience; 2 or more years aseptic processing preferred.
• Knowledge of cGMP guidelines/standards.

Preferred Skills:

• 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.