Quality Assurance Documentation Specialist

Quality Assurance Documentation Specialist

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INTERESTED CANDIDATES CAN SEND UPDATED RESUMES TO MAMCDONOUGH @ACTALENTSERVICES .COM OR TEXT MARISA . 1302 TO SET UP A PHONE INTERVIEW!

This role is fully documentation with little to no lab work.

The Quality Assurance Technician will perform quality control inspection and disposition of materials and products according to established specifications. This role ensures compliance with applicable FDA, state OSHA, and ISO regulations and standards by performing QC inspections using measuring instruments and inspection methods. The technician will identify and manage non-conforming materials or products in accordance with the Quality System and perform a variety of tasks under limited supervision.

• Perform reviews of batch production records and manufacturing records as part of lot release activities.
• Coordinate and track CAPA, NCR, and Deviation records, ensuring timely completion of tasks.
• Coordinate and track the site environmental monitoring (EM) testing program.
• Assist teams in problem solving and root cause analysis for quality inexpensive.
• Develop, review, and release quarterly EM trending reports and bring significant trends to management attention.
• Providerega input based on knowledge and experience with batch release requirements.
• Support QMS Operations related activities for all CGMP departments.
• Conduct Quality Control activities at processing or distribution sites, including inspections of incoming materials, and finished products.
• Maintain accurate and complete records of Quality Control activities, following Good Documentation Practices.
• Support gowning qualification and training.
• Ensure timely issuance, review, and approval of Microbiology and EM testing results.
• Interface with colleagues to ensure effective corrective and preventive actions for recurring product/process discrepancies.
• Assist in the review and approval of equipment qualifications.
• Assist in the review of Calibration and Preventative Maintenance reviews.
• Assist in hosting onsite regulatory audits and inspections.

• Bachelor’s Degree in a Life Science discipline or related field.
• 1-2 years of relevant industry experience with GMP, GDP, or GXP, within a Medical Device, Pharmaceutical, or Tissue commercial organization.
• Experience in an FDA‑regulated environment, particularly in medical device, human tissue, or pharmaceutical manufacturing.
• Proficiency in Microsoft Excel.
• Experience writing Standard Operatingisme Procedures and Work Instructions.
• Familiarity with Quality System elements for CAPA, Non‑Conforming Reports (NCRs), and Deviations.

• Knowledge in biology, human tissue, skin processing, and compliance.

The position is primarily desk‑based with some inspection duties and occasional work in clean rooms or labs. Candidates should be comfortable working around human tissue. Work hours are flexible and may include shifts: 1st shift Monday‑Friday 7:00 AM‑3:30 PM, and 2nd shift Monday‑Friday 3:00 PM‑11:30 PM. The work setting includes a brand‑new, state‑of‑the‑art facility in Vandalia Baking, OH, reflecting a company experiencing rapid growth.

This is a Contract position based out of Vandalia, OH.

Location:

Vandalia, OH.

The pay range for this position is $26.50 - $26.50/hr eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre‑tax and Roth способ contributions available
• Life Insurance (Voluntary Life & AD&DD for the employee and dependents)
• Short- and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, vacation or sick leave)

Workplace Type:
This is a fully onsite position in Vandalia, OH. Final date to receive applications:
This…