Job Description
The Quality Technician (Support & Document Control) supports the Quality Department by assisting with day-to-day quality operations, production support activities, and the management of controlled documentation in accordance with established procedures, current Good Manufacturing Practices (cGMP), and 21 CFR Part 111. This role focuses on production clearances, label issuance, raw material sampling, and document control activities, including batch record management, log maintenance, and record archiving. The position is well-suited for a detail-oriented individual who plays a key support role in maintaining compliance, traceability, and production readiness within a regulated manufacturing environment.
Responsibilities:
Support the Quality Technicians with production clearances and line readiness activities.
Issue, control, and reconcile labels in accordance with approved procedures.
Perform raw material sampling following established SOPs.
Verify material and label status prior to release for production.
Print, assemble, and issue Master Batch Records (MBRs) for production runs.
Scan, index, and archive completed MBRs and production documentation.
Maintain and update quality and production logs (MBRs, labels, materials, etc.).
Ensure controlled documents are current, accurate, and properly stored.
Retrieve quality records for audits, reviews, and internal requests.
Support document revisions by distributing updated documents and removing obsolete versions.
Follow Good Documentation Practices (GDP) at all times.
Identify documentation errors or discrepancies and escalate to Quality leadership.
Communicate effectively with Production, Warehouse, and Quality teams.
Support the implementation and maintenance of quality systems, regulatory programs, and certification requirements across the facility.
Support the Quality team with additional quality and documentation tasks as assigned.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Required Skills & Experience
• High school diploma or equivalent required; Associate degree preferred.
• Prior experience in Quality, Manufacturing, or Document Control preferred.
• Basic understanding of cGMP principles (training will be provided).
• Familiarity with 21 CFR Part 111 is preferred but not required.
• Strong attention to detail and ability to follow written procedures.
• Strong organizational and time-management skills, with the ability to prioritize effectively.
• Computer literacy; proficient in Microsoft Office Suite and comfortable working within digital recordkeeping systems.
• Ability to manage multiple tasks simultaneously while maintaining accuracy and compliance.
• Capable of working both independently and collaboratively within a team environment.
• Demonstrates a strong willingness to learn and grow within a regulated manufacturing setting.
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.