Manufacturing Quality Assurance Specialist

4 weeks ago

Houston, United States Empower Pharmacy Full time

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.
- Maintains accurate 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 c

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