Title: Quality Specialist - I (Assistant)

Job ID: 34043

Location: Durham, NC 27712

Duration: 12 Months

Qualifications:

Education: • Bachelor's degree. Technical emphasis in an appropriate scientific or engineering field preferred; candidates with majors in other fields will be considered if accompanied by significant relevant experience. Required Experience and Skills: • At least one year of relevant post-degree work experience in a laboratory, manufacturing, or quality position. • Evidence of good oral and written communication skills, i.e., effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills. • Attention to detail, flexibility and an awareness of production and attendant quality control problems. • Basic understanding of GMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area. Preferred Experience and Skills: • Familiarity with vaccine and/or pharmaceutical testing. • Familiarity with manufacturing batch records is a key skill necessary for success in this position; prior GMP data review experience is a strong plus. • Experience in quality assurance audits or inspection of vaccine or pharmaceutical manufacturing areas is beneficial. • Familiarity with computer systems (SAP, LIMS, electronic batch records) is a plus

Responsibilities:

The Contractor Quality Specialist (CQS) provides direct Quality support to a production area as part of a Quality IPT (Integrated Production Team) operating model. The CQS, with guidance from the IPT Quality Leadership team, ensures product / process quality and performs activities to facilitate the release of product to the marketplace. The CQS performs 100% process document / log book audits for accuracy and completeness and works closely with the assigned End to End (E2E) in a team environment to ensure timely review and documentation is done right first time. The Contractor Quality Specialist will become knowledgeable in Federal and other regulatory agency requirements and cGMPs to assure that all areas in compliance, and will train on and gain competency in activities to facilitate release of product for assigned End to End (E2E). Specific responsibilities include but are not limited to the following: • Performs 100% audit of process documents / log books to ensure completeness and accuracy for assigned End to End (E2E). Maintains any tracking databases and logs associated with this review. Coordinates with laboratory to discuss, resolve, and eliminate documentation observations. • Actively participates in the Tier process and uses this forum to escalate concerns and best practices. • Collaborates with IPT members in the identification and implementation of continuous improvement initiatives and action plans. • Prioritizes review of process documents / log books in order to maximize cycle-time efficiency. • Performs LIMS transactions required to document GMP data review.

Comments/Special Instructions

GMP Documentation Review. Not lab work. Ideal candidate has CGMP experience, Quality data review, Environmental monitoring experience.

Thanks & Regards

Vickey

Senior Pharma Recruitment Associate

Freyr, Inc.

150 College Road West, Suite 102, Princeton, NJ 08540

Phone: (732) 707-2456

www.freyrsolutions.com

Job Type: Contract

Pay: $35.00 - $40.00 per hour

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Durham, NC 27712: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

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