Quality Specialist

Job Description : Quality Specialist - I (Assistant)

Location : Durham, NC 27712

Duration : 12+ Months (Extendable)

Pay Rate : $36 / hr on W2

Qualifications :

Education Minimum Requirement : High school degree is the minimal requirement, but bachelor’s degree in a scientific discipline is preferred.

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*

• A minimum of four years of relevant post-degree work experience in GMP-related field, including Technical, Engineering, Quality or Operations.
• Evidence of leadership skills coupled with good oral and written communication skills, i.e., effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills.
• Effectiveness and creativity in approaching and solving technical problems.
• Attention to detail, flexibility and an awareness of production and quality control problems.
• Basic understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.
• Basic understanding of the use and maintenance for Microsoft applications (such as MS Excel, MS Outlook, and / or MS Word)

Preferred Experience and Skills :

• Familiarity with vaccine and / or pharmaceutical processing.
• Familiarity with batch review and batch production systems such as PAS-X, MES, etc.

Responsibilities :

The Quality Batch Review Specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Production Team) operating model.

The Quality Review Specialist, with guidance from the IPT Quality Release Lead and Quality Review Team, ensures product / process quality, performs activities to ensure that batches are reviewed for any process errors, discrepancies, and documentation errors.

When necessary, the deviation process is initiated by the Quality Batch Review Specialist through a notification process to the appropriate contacts to remediate issues / concerns associated with the production batch.

The Quality Batch Review Specialist is knowledgeable in federal and other regulatory agency requirements and cGMPs to ensure that all areas are in compliance and will train on and gain competency in activities to ensure quality and compliance of product manufactured by the functional area.

Specific responsibilities include but are not limited to the following :

1. Becomes fully trained in Client Quality SOPs, production SOPs as needed, and SAP functions as required by Quality Specialists.

2. Learns cGMPs, the manufacturing process, and Client quality systems.

3. Responsible for the review and approval of batches destined for both domestic and international markets.

4. Ensures compliance with departmental procedures.

5. Actively participates in the Tier process and uses this forum to escalate concerns and best practices.

6. Collaborates with IPT members in the identification and implementation of continuous improvement initiatives and action plans.

Comments / Special Instructions

Top Skillset- Batch record review

batch production systems such as PAS-X, MES

Additional- pharma or biotech production experience, vaccine manufacturing, Final Fill formulation,