Quality Assurance

Job Description

QA Specialist - Birmingham, AL


Industry: Pharmaceutical / Medical Device Manufacturing

Benefits, PTO, and Holiday Pay

Sirius Staffing is seeking a Quality Assurance (QA) Specialis t to support a well-established manufacturing facility in the Birmingham, Alabama area. The primary focus of this position is to support production and testing activities, assist with quality training and quality awareness, and support timely investigations.


This role provides quality and technical oversight of production and laboratory operations, with responsibilities focused on data review, QMS compliance, manufacturing and testing support, quality culture, investigation support, 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, including WFI, steam, and nitrogen.
• Review, update, and/or approve QMS documentation through the Regulus document-control system, 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 laboratories, manufacturing areas, and warehouse areas.

TrackWise Support

• Support deviations and change controls by completing records, assisting with 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 degree in Chemistry, Biology, Engineering, or a related field; relevant experience may be considered in place of a degree.
• Minimum of two years of experience in pharmaceutical or medical-device manufacturing.
• Strong working knowledge of FDA cGMP and/or QSR requirements.
• Proficiency in the Microsoft Office Suite, including Word, Excel, and Access.
• High attention to detail, with strong organizational and communication skills.
• Solid interpersonal skills and a 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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Meet Your Recruiter

Alicia Paslawsky