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STAQ Pharma seeks a Laboratory Quality Specialist to maintain and continuously improve the laboratory Quality Management System (QMS) in a regulated pharmaceutical environment. This role ensures regulatory compliance, data integrity, product quality, laboratory impartiality, and patient safety.
You will provide quality oversight for laboratory operations, testing support systems, documentation, investigations, audits, supplier and equipment quality activities, COA release, and inspection readiness. Working closely with the Laboratory Manager, you will support laboratory quality priorities, coordinate quality system activities, communicate compliance expectations, and ensure laboratory operations remain aligned with regulatory requirements and internal procedures.
Key responsibilities include:
- Maintaining and improving the laboratory QMS to ensure alignment with cGMP, GLP, applicable USP chapters, and regulatory expectations
- Reviewing and approving laboratory quality policies, SOPs, forms, logs, quality plans, and work instructions
- Managing quality system processes for deviation management, CAPA, change control, risk management, document control, training, supplier qualification, and audit readiness
- Defining, monitoring, trending, and reporting laboratory quality metrics to identify compliance risks and continuous improvement opportunities
- Overseeing quality aspects of laboratory equipment qualification, calibration, maintenance, cleaning, and environmental controls
- Reviewing and approving method implementation, transfer, verification, and validation from a quality perspective
- Supporting regulatory inspections, client audits, and internal audits
- Performing deviation investigations, CAPA, OOS/OOT investigations, change control, and COA review/release
- Reviewing laboratory trends, deviations, complaints, and audit findings to identify systemic issues
- Contributing to monthly and quarterly quality metrics reporting with trend analysis and risk escalation
- Leading or participating in continuous improvement projects
- Supporting supplier assessment and qualification activities
The role requires strong knowledge of cGMP, GLP, applicable USP expectations, FDA-regulated laboratory practices, quality systems, and risk management. You will work independently while maintaining objective quality decisions free from manufacturing pressure or conflicts of interest.
REQUIREMENTS:
- Bachelor's degree in Chemistry, Biology, Biochemistry, Microbiology, Pharmaceutical Sciences, Medical Laboratory Science, or related scientific discipline (required); advanced degree preferred
- Minimum 4 years of QA/QC experience within a pharmaceutical or regulated laboratory environment (required)
- Strong working knowledge of GxP, including cGMP, GLP, FDA-regulated laboratory expectations, and applicable USP requirements
- 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, and root cause analysis
- Ability to confidently interact with clients, auditors, laboratory staff, manufacturing partners, and leadership
- High attention to detail with strong judgment, integrity, and commitment to data integrity and patient safety
- Ability to interpret regulatory requirements and translate them into practical procedures and controls
- Proficiency with Microsoft Office (Excel, Word, PowerPoint); experience with quality management systems, LIMS, electronic document management systems, and data trending tools preferred
- Experience supporting regulatory inspections, client audits, internal audits, deviation investigations, CAPA, OOS/OOT investigations, change control, training systems, and QMS implementation preferred
- ASQ, RAC, ISO 9001, ISO 17025, Lean Six Sigma, or related quality/regulatory certification preferred but not required
- Ability to stand for extended periods and lift up to 25 lbs
- May require occasional weekend, holiday, or off-shift work
