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Quality Assurance Specialist
Job Description
Quality Assurance (QA) Specialist – Birmingham, AL
Industry: Pharmaceutical / Medical Device Manufacturing
Pay: $25/hr + Benefits PTO & Holiday Pay
Pay: $25/hr + Benefits PTO & Holiday Pay
Schedule: Mon - Fri 8a-5p
Sirius Staffing is seeking a Quality Assurance Specialist to support a well-established manufacturing facility in the Birmingham, AL area. This role provides quality and technical oversight to production and lab operations, focusing on data review, QMS compliance, and support for manufacturing and testing activities, while promoting a strong quality culture and assisting with timely investigations and issue resolution.
Key Responsibilities: (Routine QA Functions)
- Provide room clearance support before and during manufacturing activities
- Review production campaign documentation and batch records
- Perform final disposition of finished product
- Review and disposition raw materials and fill/finish components
- Audit cleanroom logbooks and utility testing data (e.g., WFI, steam, nitrogen)
- Review, update, and/or approve QMS documentation via the document control system (Regulus), including SOPs, work instructions, forms, and specifications
- Support on-the-floor operations during manufacturing campaigns for PDS Products, PDS Services, and MDS
- Provide on-call QA support for manufacturing
- Issue and reconcile product labels
- Support SAP by reviewing inspection plans
- Perform monthly GMP monitoring of labs, manufacturing areas, and the warehouse
TrackWise Support:
- Support Deviations and Change Controls by completing records, assisting in investigations, and reviewing or approving documentation
- Conduct effectiveness checks as part of CAPA activities
Continuous Improvement:
- Participate in product quality and system improvement initiatives
- Gather and analyze data to identify quality improvement opportunities
Risk Management:
- Identify product risks and ensure mitigation controls are in place to reduce risks to an acceptable level
Qualifications:
- Bachelor of Science in Chemistry, Biology, Engineering, or a related field
(Relevant experience may be considered in place of a degree) - Minimum 2 years of experience in pharmaceutical or medical device manufacturing
- Strong working knowledge of FDA cGMP and/or QSR requirements
- Proficient in Microsoft Office Suite (Word, Excel, Access)
- High attention to detail, strong organizational and communication skills
- Solid interpersonal skills and collaborative mindset
- Analytical thinking with applied statistics knowledge
- Demonstrated ability to solve complex problems and make sound decisions
Preferred Qualifications:
- Experience with ISO 13485 and/or ISO 14971
- Six Sigma certification
Sirius Staffing is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to characteristics such as race, color, national origin, religion, gender, age, marital status, disability, veteran status, citizenship status, sexual orientation, gender identity, or any other status protected by law.
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About Birmingham, AL
Discover Your Next Career Opportunity in Beautiful Birmingham, Alabama! This vibrant city nestled in the heart of the South offers a perfect blend of Southern charm and modern amenities. Known for its rich history, delicious southern cuisine, and thriving arts scene, Birmingham is a hidden gem for job seekers looking to grow their careers. Explore job opportunities near iconic landmarks like the Vulcan Park and Museum, catch a show at the Alabama Theatre, or cheer on the Birmingham Barons at Regions Field. With its lush parks, trendy galleries, and bustling cultural events, Birmingham provides an exciting backdrop for your professional journey. Start your job search today and experience the magic of Birmingham!