Position Title: Associate Quality Assurance
Work Location: New Albany, OH, 43054
Assignment Duration: 1 year (possible extension)
Work Schedule:

• Swing shift - 12 hour shifts - Must have flexibility with shifts
• 10PM - 6:30 AM - May fluctuate over the duration of the contract

Position Summary: Primary responsibilities of this position include inspecting raw materials, components, and labels, in addition to sampling raw materials, labels, and sanitary utilities, and generating/compiling quality data and reports (e.g. lot track/trace, incidents).
 
Background & Context: Supplement to the team.
 
Key Responsibilities:

• Will also assist with document review and initiate incidents, as well as coordinate and compile general documents and oversee room clearance inspection.
• Provide daily guidance and support to manufacturing staff regarding compliance with Standard Operating Procedures and Work Instructions.
• Ensure regular presence on the packaging area to provide oversight to GMP operations and quality systems.
• Act as a first point of contact in case of production staff inquiries (quality related) during operations.
• Review and approve batch record documentation, assist in sampling and inspections as required and other GMP documentation in support of daily operations.
• Own, review, and approve controlled documents, including Standard Operating Procedures (SOPs), Work Instructions and Forms.
• Review and approve minor deviations.
• Adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting Environmental Health and Safety

Qualification & Experience:

• Ideal Candidate: B.S or relevant experience. GMP background is nice to have.
• Nice to have: Veeva, Trackwise, SAP, Maximo, and MES.
• Skills: quality assurance or manufacturing experience in the pharmaceutical or medical device industry
• Basic Qualifications: High school/GED + 2 years work experience or Associates degree and 6 months work experience or Bachelors degree

Must Have Skill Sets:

• Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing Technologies
• Experience in and knowledge of GMP/GCP operations or similarly regulated industry
• Highly effective verbal and written communication skills, strong interpersonal skills
• Great attention to detail and high degree of accuracy in task execution and GMP documentation
• Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues.
• Strong organizational skills, including ability to follow assignments through to completion.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 22.00/hr.