Actalent
Join to apply for the
Quality Documentation Technician
role at
Actalent .
Email MAMCDONOUGH@ACTALENTSERVICES.COM or text MARISA at 330.397.1302 to set up a phone interview.
Job Description 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.
Responsibilities
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 events.
Develop, review, and release quarterly EM trending reports and bring significant trends to management attention.
Provide 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, in‑process, 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.
Essential Skills
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 Operating Procedures and Work Instructions.
Familiarity with Quality System elements for CAPA, Non‑Conforming Reports (NCRs), and Deviations.
Additional Skills & Qualifications
Knowledge in biology, human tissue, skin processing, and compliance.
Work Environment 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, OH.
Job Type & Location Contract position based out of Vandalia, OH.
Pay And Benefits Pay range: $26.50‑$26.50/hr.
Benefits (subject to eligibility and specific elections):
Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available
Life Insurance (Voluntary Life & AD&D for employee and dependents)
Short and long‑term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Paid Time Off / Leave (PTO, vacation, or sick leave)
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Equal Opportunity Employer Actalent is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com.
#J-18808-Ljbffr
Quality Documentation Technician
role at
Actalent .
Email MAMCDONOUGH@ACTALENTSERVICES.COM or text MARISA at 330.397.1302 to set up a phone interview.
Job Description 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.
Responsibilities
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 events.
Develop, review, and release quarterly EM trending reports and bring significant trends to management attention.
Provide 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, in‑process, 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.
Essential Skills
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 Operating Procedures and Work Instructions.
Familiarity with Quality System elements for CAPA, Non‑Conforming Reports (NCRs), and Deviations.
Additional Skills & Qualifications
Knowledge in biology, human tissue, skin processing, and compliance.
Work Environment 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, OH.
Job Type & Location Contract position based out of Vandalia, OH.
Pay And Benefits Pay range: $26.50‑$26.50/hr.
Benefits (subject to eligibility and specific elections):
Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available
Life Insurance (Voluntary Life & AD&D for employee and dependents)
Short and long‑term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Paid Time Off / Leave (PTO, vacation, or sick leave)
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Equal Opportunity Employer Actalent is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com.
#J-18808-Ljbffr