Sr Quality Specialist, Systems Location: Rochester, Michigan

Employment Type: Full Time

We are seeking a Senior Quality Specialist to monitor, track, and trend Non‑Conformances, CAPA, complaints, and other Quality Systems. The role includes assessing risk levels associated with Non‑Conformances, escalating issues to management, gathering, analyzing, reporting, and presenting metrics to the Quality Systems and Technology Department, and ensuring field alerts are investigated within 72 hours.

Key Accountabilities

Monitors, tracks, and trends CAPA and complaints, tracks due dates, analyzes data, prepares reports, and presents findings

Assesses risk level associated with Non‑Conformances, notifies Planning/Scheduling, and escalates to management

Reviews or approves Site Quality Reviews of complaint investigations and monitors complaints to ensure potential field alerts are investigated within 72 hours

Attends meetings as requested in place of the Manager Quality Systems, determining priorities and making appropriate decisions

Initiates communication due dates for Quality Systems (NCRs, CAPA, Complaints, etc.) to ensure they are completed on time

Reviews current Quality Systems, works with cross functional teams, and recommends improvements

Coordinates and prepares metrics and materials for Quality Council and Management Review

Performs and evaluates CAPA effectiveness checks

Qualifications

BA/BS in Life Sciences with a minimum of 6+ years of experience in the pharmaceutical industry, OR MS with 4+ years of relevant experience in the pharmaceutical industry

Strong knowledge of current state, federal, and local standards and regulations (e.g., cGMP, OSHA, DEA)

Strong knowledge of 21‑CFR‑210, 21‑CFR‑211, and ICH Guidelines

Technical and quality background related to pharmaceuticals

Skills & Abilities

Strong communication skills

Strong focus on quality and proven ability to apply a high degree of integrity

Customer / Stakeholder focus (understanding business plans and operating environment)

Technical writing ability

Clear problem‑solving and decision‑making skill

Physical Requirements Walk across plant / warehouse

EEO Statement We firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices.

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