Quality Assurance Manager

Diversified Sourcing Solutions; Alabama; On-site; USD 37,000 - 44,000; Full time

Job summary

Diversified Sourcing Solutions is seeking a highly detail-oriented QA Specialist to support Quality Assurance activities within a regulated pharmaceutical manufacturing environment. This role emphasizes documentation accuracy, GMP compliance, and timely resolution of quality issues.

The QA Specialist will review batch records, support deviation writing, and contribute to continuous improvement while maintaining audit-ready documentation and strict gowning procedures in ISO Class 8 cleanrooms.

Qualifications

• Experience in Quality Assurance, documentation review, deviation writing, or GMP compliance within pharmaceutical, biotechnology, or other regulated manufacturing environments preferred.
• Familiarity with GMP documentation practices, batch record review, and quality systems.
• Strong attention to detail, accuracy, and organizational skills.
• Ability to manage and review documentation efficiently in a fast-paced production environment.
• Comfortable working in cleanroom environments and gowning procedures.

Responsibilities

• Issue, track, and maintain controlled documents in accordance with document control procedures.
• Scan, file, and organize quality and production documentation to ensure full traceability.
• Support data entry and maintenance of quality trending logs and quality system metrics.
• Perform detailed, realtime review of batch records for accuracy, completeness, and GMP compliance.
• Continuously review production logs and documentation for proper entries and adherence to procedures.
• Provide floor support to Operations to ensure batch records are completed correctly and consistently.
• Work within ISO Class 8 cleanroom environments following proper gowning procedures.
• Follow all safety procedures when working in controlled environments involving hazardous drug products.
• Identify documentation discrepancies and elevate issues promptly to the Quality team.
• Draft and support deviation reports, including initial documentation, rootcause identification, and corrective/preventive action tracking.
• Assist with investigation reporting to ensure timely closure and compliance with internal and regulatory expectations.
• Maintain organized, compliant, and auditready documentation practices at all times.

Skills

Attention to detail

Documentation review

Quality systems

Job description

Job Description

Diversified Sourcing Solutions is seeking a highly detailoriented QA Specialist to support Quality Assurance activities within a regulated pharmaceutical manufacturing environment. This role plays a critical part in ensuring documentation accuracy, GMP compliance, and timely resolution of quality issues. In addition to batch record review and documentation control, the QA Specialist will contribute to deviation writing, investigation reporting, and continuous improvement initiatives. The ideal candidate thrives in a structured environment, enjoys problemsolving, and is motivated by maintaining the highest standards of product quality and patient safety.

Key Responsibilities

• Issue, track, and maintain controlled documents in accordance with document control procedures
• Scan, file, and organize quality and production documentation to ensure full traceability
• Support data entry and maintenance of quality trending logs and quality system metrics
• Perform detailed, realtime review of batch records for accuracy, completeness, and GMP compliance
• Continuously review production logs and documentation for proper entries and adherence to procedures
• Provide floor support to Operations to ensure batch records are completed correctly and consistently
• Work within ISO Class 8 cleanroom environments following proper gowning procedures
• Follow all safety procedures when working in controlled environments involving hazardous drug products
• Identify documentation discrepancies and elevate issues promptly to the Quality team
• Draft and support deviation reports, including initial documentation, rootcause identification, and corrective/preventive action tracking
• Assist with investigation reporting to ensure timely closure and compliance with internal and regulatory expectations
• Maintain organized, compliant, and auditready documentation practices at all times

Qualifications

• Experience in Quality Assurance, documentation review, deviation writing, or GMP compliance within pharmaceutical, biotechnology, or other regulated manufacturing environments preferred
• Familiarity with GMP documentation practices, batch record review, and quality systems
• Strong attention to detail, accuracy, and organizational skills
• Ability to manage and review documentation efficiently in a fastpaced production environment
• Comfortable working in cleanroom environments and following gowning procedures

Compensation

• $27.00 – $32.00 per hour, depending on experience

Schedule

• 1st Shift, 8:30 AM – 5:00 PM

Diversified Sourcing Solutions provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics.

Company Description

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