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Full-time
bachelor degree, postgraduate degree
Comprehensive medical coverage, Dental, Vision, Life insurance, Disability insurance, 401(k) with company match
Posted 7d ago
~40 hrs/week
Responsibilities
The Laboratory Quality Specialist maintains and improves the laboratory Quality Management System to ensure regulatory compliance, data integrity, and patient safety. They provide quality oversight for laboratory operations, including investigations, audits, equipment qualification, and documentation review.
Requirements
Candidates must have a Bachelor's degree in a scientific discipline and at least 4 years of QA/QC experience in a regulated pharmaceutical laboratory. Strong knowledge of GxP, FDA expectations, and quality systems is required, along with excellent communication and technical writing skills.
Full job description
Job Summary:
The Laboratory Quality Specialist is responsible for maintaining and continuously improving the laboratory Quality Management System (QMS) in support of regulatory compliance, data integrity, product quality, laboratory impartiality, and patient safety within a regulated pharmaceutical laboratory environment. This role provides quality oversight for laboratory operations, testing support systems, documentation, investigations, audits, supplier and equipment quality activities, COA release, and inspection readiness.
This position works closely with the Laboratory Manager to support laboratory quality priorities, coordinate quality system activities, communicate compliance expectations, and help ensure laboratory operations remain aligned with regulatory requirements, internal procedures, continuous improvement goals, and the impartiality of the laboratory from manufacturing operations. The role requires strong knowledge of cGMP, GLP, applicable USP expectations, FDA-regulated laboratory practices, quality systems, risk management, and effective cross-functional collaboration.
Responsibilities:
Quality Management System Support & Governance
Maintain and improve the laboratory QMS to ensure alignment with cGMP, GLP, applicable USP chapters, regulatory expectations, internal quality standards, and laboratory impartiality requirements.
Review and approve laboratory quality policies, SOPs, forms, logs, quality plans, and work instructions.
Maintain quality system processes for deviation management, CAPA, change control, risk management, document control, training, supplier qualification, audit readiness, management review, and objective quality decision-making independent from manufacturing pressure or conflicts of interest.
Define, monitor, trend, and report laboratory quality metrics to identify compliance risks, impartiality risks, recurring issues, and continuous improvement opportunities.
Partner with laboratory leadership and cross-functional stakeholders to ensure the QMS supports reliable testing, defensible data, timely investigations, compliant decisions, and quality system gap remediation.
Other duties as assigned.
Regulatory Compliance, Documentation, Data Integrity & Continuous Improvement
Oversee quality aspects of laboratory equipment qualification, calibration, maintenance, cleaning, environmental controls, temperature monitoring, and computerized or electronic laboratory systems.
Review and approve method implementation, transfer, verification, validation, and lifecycle maintenance from a quality and regulatory perspective.
Support regulatory inspections, client audits and internal audits.
Perform deviation investigations, CAPA, OOS/OOT investigations, change control, training qualifications, and COA review/release.
Review laboratory trends, deviations, complaints, audit findings, analytical report accuracy, and process performance to identify systemic issues and recommend preventive actions.
Contribute to monthly and quarterly quality metrics reporting, including trend analysis, risk escalation, and action tracking.
Lead or participate in continuous improvement projects that strengthen laboratory compliance, quality processes, efficiency, documentation, and operational reliability.
Support supplier assessment and qualification activities for laboratory materials, services, contract testing laboratories, calibration providers, and critical vendors.
Required Skills/Abilities:
Strong working knowledge of GxP, including cGMP, GLP, FDA-regulated laboratory expectations, applicable USP requirements, and pharmaceutical quality systems.
Demonstrated ability to maintain and improve laboratory QMS, including document control, training, deviations, CAPA, change control, audits, supplier quality, management review, data integrity, and impartiality controls.
Excellent written and verbal communication skills, including technical writing, investigation documentation, root cause analysis, and client or auditor communication.
Ability to confidently interact with clients, auditors, laboratory staff, manufacturing partners, leadership, and internal stakeholders while supporting independent, objective quality decisions.
High attention to detail with strong judgment, integrity, confidentiality, and commitment to data integrity, patient safety, and laboratory impartiality.
Ability to interpret regulatory requirements and translate them into practical procedures, training, controls, and quality decisions.
Proficiency with Microsoft Office, including Excel, Word, and PowerPoint; experience with quality management systems, LIMS, electronic document management systems, and data trending tools preferred.
Education and Experience:
Bachelor’s degree in Chemistry, Biology, Biochemistry, Microbiology, Pharmaceutical Sciences, Medical Laboratory Science, or a related scientific discipline required; advanced degree preferred.
Minimum of 4 years of QA /QC experience within a pharmaceutical or regulated laboratory environment required.
Experience supporting regulatory inspections, client audits, internal audits, deviation investigations, CAPA, OOS/OOT investigations, change control, training systems, analytical report and COA review/release, and QMS implementation preferred.
ASQ, RAC, ISO 9001, ISO 17025, Lean Six Sigma, or related quality/regulatory certification preferred but not required.
Physical Requirements:
Ability to stand for extended periods while performing laboratory procedures.
Ability to lift up to 25 lbs. (media, solvent containers, equipment parts).
Work performed in controlled laboratory environments.
Position may require occasional weekend, holiday, or off-shift work depending on laboratory needs.
Benefits:
Excellent full-time benefits, including comprehensive medical coverage, dental, and vision options.
Bringing Safety, Transparency, Availability, and Quality to Outsourced Medications.
Industry
Pharmaceutical Manufacturing
Company size
201-500 employees
Founded
2018
Headquarters
Denver, Colorado
LinkedIn followers
6,796
Total funding
$69M
STAQ Pharma | 503B Outsourcing Supplier Strengthening the Healthcare Supply Chain
Our mission is to ensure the reliable supply of critical medications, reducing drug shortages and improving patient care.
As a hospital-owned and directed outsourcing supplier, we are dedicated to strengthening the supply chain, understanding provider needs, and ensuring patients receive the safest medication.
STAQ Pharma’s core values—Safety, Transparency, Availability, and Quality—define our commitment to delivering reliable outsourced medications. These principles guide every aspect of our operations, ensuring patient safety, open communication, product accessibility, and uncompromising standards.
With facilities in Denver, CO, and Columbus, OH, STAQ Pharma is licensed nationwide and ships to over 800 healthcare locations monthly. Our proactive inventory management and rigorous quality control make us a trusted partner for healthcare systems across the country.
🔗 Learn more: staqpharma.com
Offices: Denver, Colorado 80239, US · Columbus, Ohio 43228, US
Health CareBiotechnologyMedicalPharmaceuticalTherapeutics
How many Management & Leadership jobs are open in Columbus, OH right now?
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Companies currently hiring include JPMorganChase, Department of Animal Sciences at The Ohio State University, Nationwide Children's Hospital, Nationwide, Huntington National Bank, among others. Browse the listings above to see every active employer.
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