QA Associate III/Sr. QA Associate I

Overview:

Job Description: This function is responsible for supporting the daily manufacturing and facility operations along with project support.  Functions include proactive support of change control assessments, documentation reviews and validation review/support.  Functions also include reactive support of discrepancy identification and resolution on the floor, Investigation Team Support, TrackWise Deviations, and reporting operational metrics. This function supports and communicates events to shift leadership daily and thresholds when they are outside of the area of responsibility.

Responsibilities:

• Ensures compliance to internal procedures, policies, and standards, as well as all relevant State, Federal and International regulations during oversight of the operations.
• Approve complaints, change controls, deviations, CAPA, batch records, validation reports and other controlled documents
• Identifies compliance risks and develops sound rationale as basis for audit observations.
• Supports the coordination activities and assists with interactions during regulatory agency inspections
• Perform internal audits and author annual product reviews. 
• Participates in the review and revision of Compliance-related controlled documents. 

Qualifications:

Minimum Education & Experience Requirements: Requires a Bachelor’s degree in a scientific discipline or equivalent with a minimum of 5 - 8 years’ experience in a Quality Assurance role in the pharmaceutical industry.

Knowledge/Skills Needed: Strong written and oral communication skills. A thorough understanding of the regulatory process from GLP through commercial manufacturing. Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues. Experience in sterile and aseptic product qualification and quality. Extensive knowledge of US and European Drug Product GMP requirements and associated guidelines. Experience in implementation and administration of quality systems for drug product development, manufacturing and quality control operations. Project management experience including scheduling, tracking and auditing. Experience in change management and deviation resolution including CAPA systems.   Experience in participating in pharmaceutical technology transfer teams. Experience in the qualification of facilities, utilities, equipment and processes.

Personal Attributes Needed: Team Player committed to quality; motivated self-starter; detail and results oriented; Well organized, efficient worker with good communication skills; innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks. Ability to increase others knowledge of US end European GMP regulations and guidance. Teacher level knowledge of GMP's. Demonstrated leadership skills with a high degree of independence and limited oversight. Demonstrated success with increasing levels of organizational responsibility.

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