Pharma QC Technician – Cleanroom & Documentation Focus

STAQ Pharma Inc; Columbus (OH); On-site; USD 52,000 - 76,000; Full time

Benefits offered by this job

Medical insurance and benefits

401(k) retirement plan with employer

Paid time off

Job summary

STAQ Pharma Inc is seeking a Quality Control Technician in Columbus, OH to support QC functions in a 503B pharmaceutical manufacturing environment. You will coordinate sample prep, external lab submissions, environmental monitoring, retention materials, and regulatory documentation to ensure product quality and patient safety.

The role involves reviewing GMP documentation, assisting with investigations and CAPAs, and collaborating with Production, QA, QC, and external vendors to maintain

Qualifications

• Associate degree in the sciences or equivalent experience preferred.
• At least 1 year of Quality Control Technician experience preferred.
• Pharmaceutical, medical device, biotechnology, laboratory, sterile manufacturing, or regulated manufacturing experience preferred.
• Familiarity with cGMP, GDP, FDA-regulated environments, quality documentation, or controlled procedures preferred.
• Strong attention to detail and ability to review records, forms, and logs for completeness and accuracy.
• Excellent written, verbal, interpersonal, and independent judgment skills.
• Ability to work in a fast-paced environment with changing priorities, competing deadlines, and cross-functional requests.
• Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and ability to learn vendor portals or internal quality systems.
• Must be able to speak, read, and write in English.
• Must be a team player with a professional, quality-focused, and patient-safety mindset.

Responsibilities

• Coordinate QC sample preparation and shipment/submission of samples to external laboratories for environmental monitoring, microbiological, raw material, in-process, finished product, and other required testing activities.
• Use third-party laboratory web portals, paper submission forms, and internal tracking tools to support accurate sample submission, chain-of-custody, and follow-up on required testing.
• Assist with environmental monitoring and microbiological sample evaluation activities, including organizing samples, reviewing forms, and escalating missing, incomplete, or questionable information.
• Maintain retention materials, including organization, tracking, storage support, and disposal when required by procedure.
• Carry out Quality review and release for raw materials, APIs, excipients, sterile supplies, and other incoming materials per established specifications.
• Perform sampling and inspection of in-process and finished products according to approved procedures, sampling plans, and quality expectations.
• Perform filter integrity testing per established procedures.
• Coordinate biohazard waste destruction activities in accordance with internal procedures and safety requirements.
• Generate, issue, organize, or maintain logbooks and controlled documents as assigned.
• Review GMP documents, including production environmental monitoring forms, room logs, equipment logs, sample forms, testing data,and related quality records for accuracy, completeness, and GDP expectations.
• Support investigations, deviations, CAPAs, and continuous improvement activities by gathering information, reviewing documentation, and helping identify appropriate corrective or preventive actions.
• Support quality management system activities, including document control, training program support, and cross-functional quality initiatives.
• Work closely with Production, QA, QC, Warehouse, and external laboratory vendors to support timely sample flow, material review, documentation accuracy, and quality communication.
• Identify and elevate potential documentation errors, sample discrepancies, environmental monitoring concerns, material issues, or process deviations to the appropriate quality leadership.
• Follow all applicable cGMP, GDP, SOP, OSHA, FDA, and company policy requirements.
• Perform other duties as assigned based on business and quality needs.

Skills

Attention to detail

Team player

Communication

Microsoft Office

English proficiency

Education

Associate degree in sciences

Tools

Vendor portals

Quality systems software

Job description

STAQ Pharma Inc is seeking a Quality Control Technician in Columbus, OH to support QC functions in a 503B pharmaceutical manufacturing environment. You will coordinate sample prep, external lab submissions, environmental monitoring, retention materials, and regulatory documentation to ensure product quality and patient safety.

The role involves reviewing GMP documentation, assisting with investigations and CAPAs, and collaborating with Production, QA, QC, and external vendors to maintain