Manufacturing Quality Assurance Specialist II - 2nd Shift

POSITION TITLE: QA Specialist Level II
REPORTS TO: (Manager’s title) QA Senior Supervisor
DEPARTMENT: Quality Assurance
LOCATION: Lexington
FLSA Status (US Only): Exempt or Non-Exempt
Please provide definitions for all acronyms. All fields must be completed.
ROLE SUMMARY
Summarize the primary purpose and key responsibilities of the role.
It may be helpful to complete this section after you have finished the other sections of the document.

ROLE SUMMARY
Responsible for on-shift support of manufacturing operations providing quality involvement and oversight during all stages of pharmaceutical development, manufacturing and testing. Also responsible for review of controlled cGMP documentation and manufacturing records including any deviations or OOS that may have occurred during lot production. Participates during the release of raw materials, intermediates and final products. Performs internal and external audits of facilities and products, observes critical operations and procedures as they occur, audits documentation, records activities and keeps management informed on quality issues.

ROLE RESPONSIBILITIES
In order of importance, indicate the primary responsibilities critical to the performance of the role. Identify 5-8 key areas that highlight accountability and level of judgment required. Ensure GMP tasks and those required by regulation are clearly documented.

ROLE RESPONSIBILITIES
• Supports on-shift manufacturing operations and activities including but not limited to real time auditing of production batch records, sampling and AQL, line clearances.
• Supports the development and maintenance of Quality Systems as appropriate.
• Lead onboarding and training efforts for new QA specialists, manufacturing personnel, and support staff. Ensuring consistent knowledge transfer and alignment with site procedures.
• Communicate complex quality concepts clearly to accelerate team readiness and performance.
• Leads continuous improvement objectives to assure compliance with DEA and FDA regulations.
• Advises senior management on findings and recommendations related to internal and external auditing.
• Manages deviation, OOS, CAPA and Change Control Systems:
◦ Evaluate proposed changes to processes, equipment, materials, or documentation to ensure compliance with regulatory and quality standards.
◦ Serve as a key resource for deviation investigations, documentation, and CAPA development. Applying strong analytical skills and root cause analysis to support compliance and audit readiness.
◦ Ensure timely implementation and effectiveness checks of CAPAs to prevent recurrence of quality issues.
• Reviews, and approves cGMP documentation including but not limited to procedures, batch records, validation protocols, development reports, specifications, raw data, executed batch records, material and batch disposition, and other related documents.
• Develops and maintains metrics and trending reports for Compliance-related activities.
• Reviews and approves product complaint investigations and assists with investigations.
• Performs activities associated with various one-time or on-going projects (from participation level to project manager).
• Collaborates with departments and external suppliers regarding quality concerns.
• Participates and/or coordinates Compliance Assessments of departments as necessary (GXP, Part 11, etc.).
• Supports regulatory inspections and customer audits.
• Supports quality related inventory functions in Enterprise Resource Planning software (D365, JDE, etc).
• Supports client communications via in-person or digital meetings, email, and other communication platforms.
• Assists Manager/Supervisor with daily and project activities as needed.
◦ Coordinate QA co