Quality Control Specialist

# Quality Control Specialist

## About the Role

We are seeking a skilled, detail-oriented, and dependable **Quality Control Specialist** to support GMP analytical testing, data review, documentation, and day-to-day quality control laboratory operations. This role is ideal for someone with hands-on laboratory experience who is comfortable working with approved procedures, analytical methods, regulated documentation, and quality-focused processes.

The Quality Control Specialist will perform routine QC assays with increased independence, prepare and manage samples, document work accurately, support first-pass data review, and contribute to reliable laboratory operations. This position plays an important role in helping ensure that testing activities are performed consistently, accurately, and in compliance with Good Manufacturing Practice standards, approved SOPs, and internal quality requirements.

The ideal candidate is organized, careful, and quality-minded. They should be able to follow procedures precisely, recognize issues, communicate clearly, and support a compliant laboratory environment. This role may also include helping draft deviation documentation and mentoring junior analysts as they develop their QC skills.

## Key Responsibilities

* Execute routine QC analytical assays according to approved SOPs, test methods, protocols, and GMP requirements.
* Prepare, label, handle, store, and manage samples, reagents, standards, controls, and laboratory materials according to established procedures.
* Perform testing with increasing independence while maintaining accuracy, consistency, and compliance.
* Maintain clean, organized, and inspection-ready laboratory work areas.
* Clean, maintain, and verify readiness of laboratory instruments, equipment, and workstations.
* Document testing activities, observations, calculations, results, and related information accurately and in accordance with GMP documentation standards.
* Conduct first-pass data checks to support accuracy, completeness, consistency, and compliance before formal review.
* Review laboratory records for obvious errors, missing information, calculation issues, transcription concerns, or procedural inconsistencies.
* Assist with drafting deviations, investigations, corrective actions, and supporting documentation when unexpected results or procedural issues occur.
* Escalate testing issues, data concerns, instrument problems, out-of-specification observations, or procedural deviations to appropriate team members.
* Support QC documentation activities, including worksheets, logbooks, forms, test records, equipment records, and sample tracking materials.
* Follow laboratory safety requirements, GMP procedures, data integrity practices, and company quality standards.
* Support operational reliability by helping ensure materials, instruments, reagents, and documentation are available and ready for use.
* Participate in laboratory readiness activities, audits, inspections, training, and continuous improvement efforts.
* Mentor junior analysts by providing guidance on routine procedures, documentation expectations, laboratory practices, and quality standards.
* Collaborate with QC analysts, supervisors, quality assurance, manufacturing, and other cross-functional teams as needed.

## Required Qualifications

* Experience working in a quality control, analytical laboratory, pharmaceutical, biotechnology, medical device, or regulated manufacturing environment.
* Hands-on experience performing laboratory testing according to approved procedures.
* Familiarity with GMP, Good Documentation Practices, laboratory safety practices, and data integrity expectations.
* Ability to accurately follow SOPs, test methods, protocols, and laboratory instructions.
* Strong attention to detail and ability to recognize errors, inconsistencies, or unusual results.
* Experience preparing and managing samples, reagents, standards, or controls.
* Ability to document laboratory work clearly, accurately, and in a timely manner.
* Basic understanding of laboratory instruments, analytical methods, and routine equipment care.
* Strong organizational skills and ability to manage multiple testing tasks or priorities.
* Ability to communicate issues clearly and escalate concerns appropriately.
* Comfortable working independently while collaborating with QC team members and cross-functional partners.

## Preferred Qualifications

* Associate’s or bachelor’s degree in chemistry, biology, biochemistry, microbiology, pharmaceutical sciences, laboratory science, or a related scientific field.
* Experience performing GMP analytical testing in a pharmaceutical, biotechnology, biologics, cell therapy, gene therapy, or medical device environment.
* Experience with first-pass data review, laboratory record review, or quality documentation.
* Familiarity with deviations, investigations, CAPAs, change controls, or audit support.
* Experience with laboratory information management systems, electronic notebooks, chromatography data systems, or other QC documentation platforms.
* Experience mentoring junior analysts or supporting laboratory training activities.
* Familiarity with common QC methods such as HPLC, GC, UV-Vis, pH, osmolality, appearance testing, wet chemistry, microbiological testing, or compendial methods.
* Understanding of ALCOA+ data integrity principles and inspection-readiness expectations.

## Ideal Candidate Profile

The ideal candidate is a careful and reliable QC professional who understands the importance of accuracy, documentation, and compliance in a GMP laboratory. This person takes pride in performing work correctly, maintaining organized records, and helping ensure that laboratory results are trustworthy and complete.

They should be comfortable performing routine testing with independence while knowing when to ask questions or escalate concerns. The right candidate will be detail-oriented, steady under pressure, and committed to maintaining high standards for data quality, sample handling, instrument care, and laboratory documentation.

This person should also enjoy supporting others. They may help junior analysts understand laboratory procedures, documentation requirements, and quality expectations while contributing to a positive and dependable QC team environment.

## Work Environment

This position is typically performed in a regulated laboratory environment and may require standing for extended periods, using laboratory instruments, handling samples and reagents, wearing required personal protective equipment, and following safety and contamination-control procedures.

The Quality Control Specialist may work closely with QC leadership, analysts, quality assurance, manufacturing, and other operational teams. The role requires strong attention to detail, careful documentation, and consistent adherence to approved procedures and quality standards.

## Compensation and Benefits

Compensation will be based on experience, qualifications, and overall fit for the role. Benefits may include:

* Competitive salary
* Full-time employment
* Health, dental, and vision benefits
* Paid time off
* Retirement plan options
* Professional development opportunities
* Training and career growth within quality control or quality assurance
* Collaborative laboratory environment
* Opportunity to support important product quality and compliance activities

## Equal Opportunity Statement

We are an equal opportunity employer and welcome applicants from all backgrounds. Employment decisions are based on qualifications, experience, skills, and business needs. We are committed to maintaining a respectful, inclusive, and compliant work environment.