MQA Compliance Specialist in Raleigh, NC at Volt

Date Posted: 11/8/2020

Job Snapshot

  • Employee Type:
  • Location:
    Raleigh, NC
  • Job Type:
  • Duration:
    24 weeks
  • Date Posted:
  • Job ID:
  • Contact Name
    Volt Branch
  • Phone
    (919) 829-1660

Job Description

Giant Pharmaceutical Company in Raleigh, NC is hiring - MQA Compliance Specialist!! 

Weekend Shift (7am - 7pm Friday - Sunday) - $23/hr FLAT (3mo - possible temp to hire) 

Job responsibilities:

Provide quality oversight to all manufacturing areas to ensure product quality and SOP/GMP compliance at the Raleigh Manufacturing Facility. Has extensive knowledge of the manufacturing process and routinely evaluates and resolves process issues in cooperation with Production and support personnel to ensure product safety. Works closely with Production personnel to complete on- the-floor, in-process batch record review, resolve all batch related issues, and ensure proper good documentation practices. Recommend corrective actions or process improvements that will eliminate the potential for manufacturing deviations.  

This person must be able to: Required to be on-the-floor and present to provide quality oversight for all critical manufacturing processes. Ability to make independent decisions regarding quality related concerns or issues. Works closely with Quality Management, as needed. Demonstrate a proficient knowledge of the manufacturing process and site procedures. Addresses daily quality concerns and questions related to operating and environmental issues. Clearly communicate complex issues to Management personnel. Evaluates the manufacturing areas for recommended improvements that will eliminate the potential for deviations. Work closely with Production personnel to complete in-process batch record review, resolve batch related issues, and complete timely final batch record approvals in order to meet release scheduling. Completes gown qualification and maintains status for entry into Aseptic processing area.

Must be able to demonstrate a sound knowledge of aseptic gowning practices. Identify deviations and ensure the deviations are initiated by the appropriate personnel.  Initiate or execute Action Plan requirements as needed to address investigation or compliance related activities. Assists in analysis of inspection rejects; assists in investigation of causes and implementation of corrective actions. Performs AQL checks on product when necessary and maintain AQL qualification status. Perform and document assessments of aseptic behavior inside the aseptic manufacturing area during filling, capping, and lyophilizer loading/unloading activities. Incumbent must be able to provide real-time aseptic technique coaching and risk mitigation in the event of an aseptic technique violation. Inspect the physical conditions of the aseptic manufacturing area on a routine basis.

Provide good aseptic technique and gown re-training to individuals, as required per the RPN program. Provide backup support to the Environmental Monitor group as needed and as approved by management.  
Candidate Qualifications: • Bachelor’s degree in Scientific field of study – additional Quality certifications a plus • 3+ years of experience in a Quality role in the Pharmaceutical Manufacturing Industry   • Must have a visual acuity to detect defects and AQL checks, excellent attention to detail and ability to communicate effectively at all levels  
Physical Requirements of the Role Position is exposed to a number of environments, office, lab, outside, plant floor, etc. This role is continuously sitting and typing. Frequently talking and using eye and hand coordination. Occasionally requiring lifting and carrying less than 10 lbs. Standing, walking, bending over, and repetitive use of legs are done occasionally. 
Volt is an equal opportunity employer.