Senior Quality Assurance Specialist

Job Title: Sr. Quality Assurance Specialist

FLSA: Exempt

Department: Quality

Reports To: Quality Assurance Manager

Summary:  The Senior Quality Assurance Specialist owns the batch record review and product release process, exercising independent compliance judgment that directly affects product disposition. As the first role on CMC's QA track, the position requires established quality experience to lead investigations, manage change controls, and maintain the quality management system with minimal supervision. Working across CMC's pharmaceutical, cosmetic, and EPA-registered product lines, the Senior QA Specialist ensures contract manufacturing operations meet FDA cGMP, ISO 22716, and customer requirements. The role embodies CMC's commitment to Character and Commitment — making sound, defensible quality decisions consistently and with integrity — and collaborates closely with QC, Production, and Regulatory partners to keep product moving without compromising compliance.

Essential Duties and Responsibilities

Review and approve executed batch records, making release determinations that confirm compliance with SOPs, specifications, and cGMP prior to product disposition.

Manage the batch record review process end-to-end, resolving discrepancies on time and escalating systemic issues.

Lead deviation, nonconformance, and out-of-specification (OOS) investigations; determine root cause and drive corrective and preventive actions (CAPA) to closure.

Manage change controls through review and approval, assessing procedural and regulatory impact before implementation.

Develop, revise, and maintain SOPs, work instructions, and quality documentation in accordance with Good Documentation Practices.

Plan, schedule, and conduct internal and supplier (external) quality system audits per the audit schedule; document findings and track corrective actions to closure.

Serve as a subject matter expert in quality systems (21 CFR 210 & 211), drive inspection readiness, and support FDA, EPA, and customer audits and inspections.

Develop and revise Quality Technical Agreements and assess supplier change notifications to ensure impact is evaluated before implementation.

Prepare and analyze quality metrics and trending for Management Review; propose and implement corrections for negative trends.

Provide quality systems and compliance training to staff across the organization.

Support QC testing, sampling, and floor activities as a cross-training responsibility, providing backup coverage during peak demand or staff absences.

Interact regularly with leadership, peers, internal customers, and external partners to gain alignment on sound quality decisions.

Performs other duties as assigned.

 

 

Education and/or Experience, Essential Skills and Experience     

Bachelor’s degree in Chemistry, Biology, Microbiology;

OR Associates degree in Laboratory Technology;

OR degree in related technical fields

Three (3) years of cGMP quality experience in a Quality Assurance, Quality Control, or Quality Engineering role within pharmaceutical, cosmetic, or other regulated manufacturing.

Five (5) or more years of progressive quality experience.

Training and experience conducting internal and supplier audits.

Working knowledge of FDA cGMP (21 CFR Parts 210 and 211), ISO 22716, applicable USP test methods, and EPA FIFRA requirements for consumer and antimicrobial products.

Demonstrated experience with batch record review, deviation and CAPA investigations, and change control.

Proficiency in product disposition, Good Documentation Practices and SOP management.

Excellent attention to detail and analytical skills, skilled in root cause analysis and structured problem-solving tools (e.g. 5-Why, fishbone).

Strong written and verbal communication skills, with an emphasis on clear documentation and reporting.

Attention to detail, accuracy and timeliness on a consistent basis.

Ability to work collaboratively in a fast-paced environment and adapt to changing priorities.

Computer proficiency:  Microsoft Office products - Excel, Word, Outlook and Access.  Experience with Global Shop is preferred but not required.