Principal Quality Specialist- Hybrid

Azzur Group is looking for Prinical Quality Specialist who, under general supervision, coordinates site training for compliance, environmental monitoring program review, investigations, maintain and reviews Quality records and ensures timely closure, documentation control, implements site improvements, compiling quality-related metrics, and support client need per established agreements.

Responsibilities :

Responsible for maintaining the following Primary Tasks:

1. Coordinate site training program to ensure compliance among clients, ACoD staff, and regular onsite vendors.
2. Review critical/major deviations for closure, assist with root cause analyses when required and maintain CAPA records
3. Ensure quality records are closed in a timely manner such as deviations and CAPAs
4. Oversee environmental monitoring program review and related investigations
5. Oversee the review of site specific forms for adherence against approved procedures such as cleanroom cleaning forms, shipping forms, and raw material disposition forms.
6. Lead regular meetings around quality records or root cause analyses investigations
7. Work with other departments to obtain supporting documentation for quality records as needed
8. Assist with and ensure client quality requests are completed in a timely manner
9. Assist Quality management with coordination of audit preparation, participate in site audits and execution of internal site audits.

Responsible for maintaining the following Secondary Tasks:

1. Compiling quality related metrics to support quality management review.
2. Aid in the incorporation of new clients into the facility.

1. Execute and adhere to internal ACoD and client Material Management standards and specifications when additional support is needed.

1. Maintain, retain, and/or draft site quality documentation such as quality SOPs, log forms and material files

Required Education:

• Bachelor’s degree or higher in a scientific discipline (Equivalent work experience relevant to the position may be considered.)

• 9-11 yr. Experience in a Quality Assurance position.

• Cleanroom experience is highly preferred.

• Previous experience making quality decisions

• Environmental monitoring or cleanroom microbiological experience

• Documentation control and drafting experience

Benefits

Fulltime Employment with Azzur can offer you:

• Flexible PTO
• Training and Development Opportunities
• 401(k) match
• Bonus Eligibility
• Medical Benefits
• Paid Holidays
• Paternity leave
• Employee assistant program
• Pet insurance and many more

Who we are:

Fulltime Employment with Azzur can offer you:

• Flexible PTO
• Training and Development Opportunities
• 401(k) match
• Bonus Eligibility
• Medical Benefits
• Paid Holidays

Who we are:

Azzur Group is dedicated to providing clients with efficient, innovative quality and compliance solutions from Discovery to Delivery™. With more than 500 industry partners, including 80% of the top pharma/biotech manufacturers in the U.S., Azzur Group provides carefully calibrated and efficiently executed project management, process engineering, and compliance services. As one of the fastest-growing private companies in America, Azzur Group provides clients with consulting, facility solutions, engineering, validation, IT, technical, training, COD, laboratory services, and solutions they need to remain innovative and competitive.

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