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

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ROLE SUMMARY

Summarize the primary purpose and key responsibilities of the role.

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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 coverage and mentor team members across QA and manufacturing.
• Represent QA in daily Tier meetings, providing visibility into batch-related deviations and record review.
• Fill in for QA management during Senior Management Team meetings, engaging with cross-functional leadership to drive site-level improvements.
• Participate in employee interviews, contributing to hiring decisions across departments.
• Other duties as assigned.
  
  

QUALIFICATIONS

Qualifications are job related, consistent with business requirements and necessary for the performance of an essential function of this role including: education requirements the role holder must possess, such as a Bachelors, Masters or Doctorate degree, certifications or other post graduate qualifications, the type and length of experience needed to perform effectively in the role, and the skills, knowledge and attributes a candidate must possess in order to be competent in the position.

BASIC QUALIFICATIONS

• Bachelor degree in a scientific discipline (preferred experience may be substituted for education)
• At least 3 years Pharmaceutical/Medical Device cGMP quality experience
• Knowledge of data integrity principles (ALCOA ) and compliance with 21 CFR Part 11 for electronic records
• Knowledge of HPLC principles and ability to review data for accuracy and completeness
• Knowledge of microbiological testing principles and ability to review data for accuracy and completeness
• Ability to assess problems, to identify solutions, to plan and implement necessary changes
• Experience in quality systems auditing (internal and/or external) preferred
• Familiarity with electronic QMS platforms (e.g., TrackWise, MasterControl,etc).
• Experience in manufacturing aseptically filled, sterile products preferred
• Advanced knowledge of cGMP regulations and validation principles (e.g. FDA 21 CFR Part 820, ISO 13485, etc)
• Ability to work well in a team-oriented environment
• Well-developed communication and technical writing skills
• Qualified to work with controlled substances
• Experienced in leading and assisting in deviation investigations and implementation of appropriate CAPAs.
  
  

Physical Demands/qualifications:

• Employee is required to regularly use hands in order to handle materials and supplies.
• Employee is required to use computers for an extended period each day.
• Employee is required to effectively use communication by both telephone and electronic.
• Employee is required to regularly stand and walk for extended periods of time.
• Employee must occasionally lift and or move up to 25 pounds.
• Ability to use proper lifting techniques and be conscious of the work area hazards.
• Employee is required to follow all site safety procedures.
  
  

This description indicates the general nature and level of work expected. It is not designed to cover or contain a comprehensive list of activities or responsibilities required. Role Holder may be asked to perform other duties as required.

APPROVALS

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