Manufacturing Quality Assurance Specialist (Multiple Shifts) - Empower Pharmacy

Position Summary:

The Manufacturing Quality Assurance Specialist (MQA) is responsible for ensuring the quality and safety of products produced through the sterile and nonsterile manufacturing processes. MQA will be required to perform quality assurance inspections, sampling, and reviews, as well as document and report results. MQA will also assist in the development, implementation, and maintenance of the quality assurance procedures and standards.  

Duties and Responsibilities:

• Monitors, inspects, and samples manufacturing processes as required to ensure product safety and quality.
• Establishes and maintains effective working relationships with all personnel involved in the sterile and nonsterile manufacturing processes.
• Provides guidance to personnel involved in the manufacturing process as needed.
• Utilizes problem-solving and critical thinking skills to troubleshoot and resolve quality issues on the floor. This includes evaluation and disposition of non-conformances.
• Generates and releases paper GMP (Good Manufacturing Practices) batch records according to the manufacturing schedule. Verifies the components, lot numbers, and expiration dates are correct in the corresponding PK batch record.   

• Performs “rounds” through the manufacturing areas to check the following: 

• Cleaning solutions for labeling/expiry.  
• Components in the manufacturing areas for labeling/expiry.  
• Checks SOPs/Wis kept in the manufacturing area to ensures the correct version is in use.
• Checks that documentation is following GDP (Good Documentation Practices) and coordinates any necessary corrections with the appropriate operators.

• Verifies the cleanroom layout has not changed (matches EMPQ ((Environmental Monitoring Performance Qualification layout)).  
• Reviews cleaning logs and cleaning execution.

• Verifies critical steps in the manufacturing process, including but not limited to, component lot numbers/expiration dates, weight/volume, mixing, etc.
• Performs AQL (Acceptable Quality Limit) inspections as required.
• Backup Environmental Monitoring Technician by performing environmental monitoring, gown qualification, and media fill proctoring as necessary.

• Reviews Daily Inspection Work Order from Facilities to ensure cleanroom equipment is in service.
• Analyzes data and results to identify problem areas and recommends solutions.
• Maintainsaccurate documentation of quality assurance activities.
• Assists in the development of quality assurance processes and procedures.
• Ensures compliance with all applicable regulations and standards.

• Maintains a safe and clean work environment.
• Performs 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 accommodation 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 listen. 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 compound campus.  The employee is often required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. The vision abilities required by this job include close vision.  

 

Knowledge and Skills:

• Knowledge of aseptic operations, as well as state and federal regulations/guidelines.
• Must have the ability to aseptically gown enter the environmentally controlled areas daily.
• Must be able to work gowned and on feet for extended periods of time in a cleanroom setting. 
• Must be able to work around cleaning and disinfectant agents and NIOSH hazardous chemicals.
• Excellent attention to detail.
• Excellent interpersonal skills: ability to communicate effectively (orally and in writing) with all levels of management.
• Proficient in Microsoft Office Skills-Excel, Word, PowerPoint, Outlook.
• Excellent organization, prioritization Skills and the ability to multitask.

 

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:

• A high school diploma or equivalent, required.
• An associate degree preferred plus 2-4 years of related experience preferred.
• Knowledge and experience with sterile and nonsterile manufacturing.

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 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.