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Sterile Manufacturing Quality Assurance Specialist
5 months ago
TomorrowMed Pharma is a pioneering 503B manufacturing facility poised to revolutionize the pharmaceutical compounding industry. Situated in the heart of Research Triangle Park in Raleigh, NC, this brand-new cutting-edge cGMP facility adheres to strict regulatory standards set by the FDA to ensure the safety, efficacy, and quality of all our products. At TomorrowMed Pharma, we are committed to setting new standards in quality, innovation, and patient-centric care.
Driven by a passion for healthcare and a commitment to continuous improvement, we are constantly exploring new opportunities for growth and innovation in the compounding industry. With a collaborative and supportive work environment, we empower our employees to thrive and make meaningful contributions to our mission of enhancing patient care through customized medication solutions.
Join us in our pursuit of excellence and become a valued member of our team as we continue to lead the way in 503B pharmaceutical manufacturing.
The Sterile 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. This position is responsible for managing the product inspection and labeling of finished product. This role will ensure all inspection, labeling, and kitting processes adhere to cGMP, company standards and SOPs.
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 GMP paper (Good Manufacturing Practices) batch records according to the manufacturing schedule. Verifies the components, lot numbers, and expiration dates are correct in the corresponding online 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 all SOPs kept in the manufacturing area to ensure 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 and matches the 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.
- Maintains accurate documentation of quality assurance activities.
- Assists in the development of quality assurance processes and procedures.
- Creates, implements, and manages the product inspection and labeling processes; assuring visual inspectors comply with company SOPs and policies, as well as provide positive feedback regarding work performance and adherence to cGMP regulations and industry standards.
- Supports label printing activities and document review.
- Ensures compliance with all applicable regulations and standards.
- Maintains a safe and clean work environment.
- Performs other duties as assigned.
Qualifications/Requirements:
- A high school diploma or equivalent, required.
- An associate degree preferred plus 2-4 years of related experience preferred.
- Prior cGMP experience manufacturing sterile products preferred.
- 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.
- Must be able to pass a criminal background check.
Hours and Location:
1st Shift M-F 7am-4pm
2nd Shift M-F 12pm-9pm
Facility Located in Raleigh, NC 27560 in the heart of Research Triangle Park
Comprehensive benefit package is included
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