Located in Cody, Wyoming. Not a remote position. The Quality Assurance Specialist is responsible for supporting the Quality Assurance Manager in ensuring plant and production compliance with Good Manufacturing Practice (GMP) standards. This role involves on-floor product inspections, GMP compliance verification, execution of audits (internal and external), and thorough management of controlled documents, including production records, GMP forms, and site Standard Operating Procedures (SOPs). Compliance with regulatory and company quality standards is a fundamental objective of this position.

Key Duties and Responsibilities

1. On-Floor Support & Inspections

Conduct on-floor product inspections to verify quality and conformance to established specifications and standards.
Perform production area walkthroughs to assess GMP compliance and identify potential quality issues.

2. GMP Compliance Verification

Monitor and ensure adherence to GMP requirements throughout manufacturing operations.
Work closely with production teams to verify compliance with internal and external regulations.

3. Internal and External Audits

Plan, coordinate, and execute internal and external (contract manufacturer) GMP compliance audits to assess the effectiveness of quality systems and compliance to broader government regulatory requirements.
Annual travel may be required to fulfill the auditing responsibilities of the role.

4. Controlled Document Management

Maintain and manage controlled quality documents, including production records, GMP forms, SOPs, and other essential quality documentation.
Review, update, and archive controlled documents in accordance with company standards.

5. Reporting & Recordkeeping

Prepare quality assurance reports and document findings from audits, inspections, and compliance checks.
Coordinate and execute corrective action and preventive actions (CAPA) with associated documentation as needed.

6. Cross-Functional Collaboration

Work with production, operations, and quality teams to address non-conformances and implement quality improvements.

7. Lot Release and Certificate of Analysis Creation

· Review, finalize, and approve lot release paperwork ensuring completeness and accuracy.

· Obtain corrections from production personnel as needed.

8. Other Duties As Assigned

Qualifications

Minimum: Associate’s degree, bachelor’s degree preferred in a science, engineering, or related technical field (e.g., Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, Engineering) or equivalent experience in a GMP-regulated environment.
2 or more years of professional working experience in a Quality Control or Quality Assurance role within a GMP facility.
Strong attention to detail and ability to conduct thorough inspections and audits.
Excellent document management and recordkeeping skills.
Effective communication skills and ability to collaborate across departments.

Job Type: Full-time

Pay: $60,000.00 - $70,000.00 per year

Benefits:

401(k)
401(k) matching
Health insurance
Life insurance
Paid time off

Work Location: In person

Y-Tex Corporation jobs

Quality Assurance Specialist - GMP Manufacturing