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SalaryPosition Summary:
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:
Key Competencies
Additional Voluntary Benefits
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 <797>/<800> 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.
- 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.
- High School Diploma or equivalent required.
- 1+ years previous product inspection or labeling experience preferred.
- Previous cGMP or pharmaceutical manufacturing experience preferred.
- 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 complimentary onsite IV Therapy drips, enhancing your well-being and energy levels.
- Comprehensive Medical, Dental, and Vision Options: Choose from three medical plans tailored to your needs, plus options for dental and vision coverage for you and your family.
- Telehealth visits: Access board-certified Doctors anytime, anywhere for you and your family.
- Paid & Volunteer Time Off: Enjoy paid time off for personal pursuits and contribute to causes you care about with volunteer time off.
- Paid Holidays (8 scheduled; 2 floating): Celebrate with eight scheduled holidays and two floating holidays, giving you flexibility and time for personal traditions.
- Life & AD&D Coverage: Secure your and your family's financial future with life and accidental death and dismemberment (AD&D) insurance.
- FSA (Flexible Spending Account): Manage healthcare expenses smartly with pre-tax dollars in a Flexible Spending Account (FSA).
- 401K Dollar-for-Dollar Up to 4%: Invest in your future with our 401K plan, featuring a dollar-for-dollar match up to 4%.
- Company Paid Long-Term Disability: Provided at no cost, which replaces 60% of your income if you become disabled for a long period of time.
- Flexible Schedules: Balance work and life seamlessly with our flexible scheduling options.
- Rewards & Recognition Program: Your hard work doesn't go unnoticed – enjoy rewards and recognition beyond your paycheck.
Additional Voluntary Benefits
- Accident Insurance: Pays a lump sum benefit to help cover expenses following an accidental injury.
- Hospital Indemnity Insurance: Enhance your peace of mind with supplemental hospital insurance for unexpected stays.
- Critical Illness: Protect your finances from the expenses of a serious health issue.
- Short-Term Disability: Protect your income during illness or injury with short-term disability coverage.
- Supplemental Life & AD&D: Add an extra layer of financial protection for you and your loved ones with supplemental life and AD&D coverage.
- Legal Services: Access professional legal assistance to address concerns confidently.
- Identity Theft Protection: Safeguard your identity and finances with our identity theft protection benefit.
- Pet Insurance: Care for your furry family members with our pet insurance coverage.
- Employee Assistance Program: Confidential counseling and support services for a holistic approach to your well-being.
