- Professional
- Bureau à Birmingham
Asteria Health is currently looking for a Production Supervisor for their facility in Birmingham, Alabama. This individual MUST have work experience and knowledge in shipping and logistics—pharmaceutical experience is a plus. This is a cGMP working environment where all activities are performed in accordance to SOPs and procedures. With the fast-paced environment, lifesaving medications and short lead times, this hire must be able to make decisions quickly without hesitation and must be able to handle fast paced, stressful situations with ease. Team size is expected to be between 10 and up to 25 direct reports. This is an exciting time to join a company that is experiencing record growth!
Overview
The position is responsible for ensuring that customer service and order fulfillment meet scheduled production goals. Provides leadership and direction to employees and ensures new hires are trained. Maintains a safe work environment and ensures cGMPs are followed. Responsible for proper record keeping and documentation. Individual will also be working cross-functionally within the organization to facilitate the successful completion of all development projects and meet the objectives and goals.
The position is responsible for ensuring that customer service and order fulfillment meet scheduled production goals. Provides leadership and direction to employees and ensures new hires are trained. Maintains a safe work environment and ensures cGMPs are followed. Responsible for proper record keeping and documentation. Individual will also be working cross-functionally within the organization to facilitate the successful completion of all development projects and meet the objectives and goals.
Production
- Pre-production responsibilities including staffing, reading and reviewing production schedules and batch records, relevant SOPs to identify validation, production and special requirements; facilitating the room cleaning/approval process and verifying that correct components are brought into the room, and documented properly in the batch record.
- Monitors the activities of logistics personnel within assigned areas to ensure that quality and throughput are optimized and that orders are processed in a safe, cGMP compliant and timely manner.
- Attend daily shift pass down meeting prior to scheduled shift start and at the end of your shift.
- Responsible for following and ensuring compliance with SOPs and batch records. This is accomplished by:
- Routine checks of product quality.
- Observing line clearances.
- Periodic inspection of lot, control and part numbers.
- Inventory reconciliation of packaging and labeling materials.
- Work closely with support groups on the floor to concentrate on any quality or materials concerns.
- Provide consistent leadership and focus to achieve the minimum required team performance as measured by site/business KPI’s.
Personnel
- Foster a culture of open communication, collaborative engagement, and team development
- Manage associate attendance including daily monitoring of Time keeping system and actively managing associate PTO balances.
- Performance management including semi-annual and annual review.
- Corrects and manages undesirable behaviors, conflicts of company and safety policies, and cGMPs issuing disciplinary actions when appropriate.
- Enforce all Asteria Health policies and procedures consistently. Hold all employees to the same standard of performance and conduct.
Compliance and cGMP
- Must ensure strict accordance with the Batch Records and relevant SOPs, communicate documentation issues, discrepancies and material delays to the Operations Manager.
- Ensure SOPs are current and comprehensive.
- Understand and implement cGMP on the production floor.
- Address any customer complaints attributed to your work area and shift.
- Maintain effectiveness of the Quality System components relevant to this position
- Other duties as assigned
Education or Equivalent:
- Associate’s Degree required, preferably in Science in Chemistry/Pharmacy/Engineering OR
- 5 years’ experience in manufacturing or packaging operations, preferably in a pharmaceutical or regulated environment
Experience:
- Minimum 3 years’ prior experience supervising or leading groups in a similar environment
- Experience leading in a team cGMP environment preferred
- Experience working in a GMP controlled environment.
- Pharmaceutical Industry experience preferred.
Knowledge/Skills Requirements:
- Demonstrated intermediate mathematical ability.
- Strong problem solving and analytical skills.
- Excellent documentation skills.
- Possess and demonstrate excellent verbal, written and interpersonal communications skills.
- A full complement of business computer literacy skills (e.g., word processing, spreadsheets, database software etc.) is preferred. MS Office is preferred.
- Works well in a team environment.
- Effective leadership skills that foster teamwork to get results.
- Should be familiar with cGMP and safe work practices.
- Demonstrated ability to read, write, and speak clear English.
- Be able and willing to take initiative and responsibility.
- Must be dependable and show effort in improving the overall production process.
Physical Requirements:
- Ability to stand for up to 12 hours per day
- Visual Acuity (20/30 corrected vision)
- Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, talking, writing, listening
- Occasional climbing ladders/steps, walking up inclines and uneven terrain, reaching with hands and arms, stooping, kneeling, crouching, crawling, twisting, bending, handling, turning, balancing, carrying, grasping
- Occasional lifting and/or moving up to 30 pounds
