- 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 production 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.
- 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 policies and procedures consistently.
- Hold all employees to the same standard of performance and conduct.
- 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
- 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
- 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 highly preferred.
- 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.
- 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
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Production Supervisor - Birmingham, United States - Biote
Description
Biote Medical is the world leader in hormone optimization and we are adding to our team We partner with providers to take a complete approach to healthier aging through patient-specific bioidentical hormone replacement therapy and the only nutraceutical line created specifically to support hormone health.
We are currently looking for a Production Supervisor to join our team based in Birmingham, AL. This person must be based on-site in Birmingham.
Overview
This position is responsible for ensuring that production operations meet scheduled production goals. Provides leadership and direction to Production 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
Personnel
Compliance and cGMP
Education or Equivalent:
Experience:
Knowledge/Skills Requirements:
Physical Requirements:
If you're interested in this awesome opportunity, please apply today
