Product and Labeling Inspector, 503b
1 month ago
Position Summary:
The Product and Labeling Inspector is responsible for inspecting and labeling products post-production to ensure all quality standards are met for each sterile and solid dose product manufactured at Empower’s 503B facility. Inspection and Labeling personnel must adhere to 21 CFR parts 210/211 and USP
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regulations, current Good Manufacturing Practices (cGMP), and department’s Standard Operating Procedures (SOPs) to ensure quality medication is delivered to our patients.
Duties and Responsibilities:
- Visually inspects all products for defects and rejects any non-conforming units per procedure.
- Inspects and labels products in compliance with master batch records while adhering to department specific SOPs.
- Operates all equipment associated with both inspection and labeling processes.
- Performs essential calculations and completes thorough documentation.
- Performs transfer of products from the cleanroom to the Inspection and Labeling area.
- Becomes trained and qualified on the Inspection process via internal training program.
- Methodically prepares work area and supplies prior to operation and maintains a clean and organized workspace throughout the shift.
- Supports Quality unit to complete Acceptable Quality Limit (AQL) inspection for products.
- Performs ancillary tasks and duties that support the manufacturing process such as, but not limited to material preparation, label printing, inventory accounting, organization of components, and various LEAN manufacturing tasks (6S, GEMBA, Kaizen)
- Participates and/or facilitates training as assigned by Supervisor.
- Observes and aids in coaching new hires on Inspection and Labeling operations.
- Ensures all required hygienic practices and garbing are performed per company policy.
- Performs other duties and responsibilities within the department to ensure timely execution of the production schedule.
- Assist with special projects, as needed.
- Other duties, as assigned.
To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. Vision abilities required by this job include close vision. A minimum of 20/20 nearsighted vision with or without the use of corrective lenses is required. Average or normal color vision is required. Employee must be able to stand and walk for extended periods of time for consecutive days. Employees must be able to lift up to 30 lbs.
Knowledge and Skills:
- Experience with operation of equipment and/or tools preferred.
- Detail-oriented and self-motivated.
- Communicate and collaborate effectively with a team to achieve goals around safety, quality, and delivery.
- Ability to carry out detailed written or oral instructions.
- Must be able to perform rudimentary mathematical calculations.
**Key Competencies**
- Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
- Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
- Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
- Resourcefulness: Secures and deploys resources effectively and efficiently.
- Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.
- Ensures Accountability: Holds self and others accountable to meet commitments and objectives.
- Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
- Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.
Experience and Qualifications:
- High School Diploma or equivalent required.
- 1+ years previous product inspection or labeling experience preferred.
- Previous cGMP or pharmaceutical manufacturing experience preferred.
**Benefits**:
- **No-Cost Medication**: Get your prescribed compounded medications at no cost, ensuring your health without the financial burden.
- ** Onsite Health & Wellness - IV Therapy Drips**: Rejuvenate with com
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