Job Description

Accupac seeks to hire a full-time Quality Systems Investigator to join our team in Lakewood, NJ!

Basic Job Functions: This position will be responsible for conducting thorough investigations into manufacturing deviations, non-conformances, and other quality issues, ensuring all investigations are conducted in accordance with current Good Manufacturing Practices (cGMP) regulations, aiming to identify root causes, propose corrective actions, and prevent recurrence of problems while maintaining compliance with regulatory standards;.

This position will collaborate with internal Subject Matter Experts (e.g. Analytical, Manufacturing, Packaging and Quality and IT personnel). Additionally, this role will work with customers to ensure timely reporting of Quality incidents and customer concurrence with audit findings and Corrective and Preventive Actions (CAPAs). This role requires strong computer skills as well as problem-solving skills.

Essential Functions of the Job:

• Lead investigations into Quality Events and customer complaints
• Perform root cause analysis using industry standards, such as 5Whys and Fishbone diagrams
• Determine relevant corrective and preventative action
• Perform risk assessment to determine safety and efficacy of product
• Oversee timely completion of deviations, CAPAs, investigations, complaints
• Track and trend events/deviations
• Provide communication plans for ongoing deviations and CAPAs
• Maintain compliance with company policies, regulatory requirements, quality specifications, safety standards and sanitation practices
• Proactively raise quality related risks, issues, and opportunities.
• Support the organization in maintaining a work environment focused on quality, respect, open communication, collaboration, integration, and teamwork.
• Other duties as assigned.

Minimum Requirements of the Job:

• Must have knowledge of basic principles, theories and laws, and policies and procedures that pertain to investigations.
• Conduct interviews with subject matter experts
• Strong technical writing skills
• Able to quickly and accurately type and enter data
• Attention to detail
• Excellent communication and organizational skills
• Flexibility to adjust to changing priorities.

Physical Requirements: Ability to sit for long periods of time.

Supervisory Responsibilities: No

Travel: None

Education: Must have a bachelor’s degree and experience conducting investigations in a cGMP environment. Experience with process investigations and writing CAPAs preferred.

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