Qualifications:

Education: Must possess a B.A. /B.S. degree (preferably in Science or Engineering).

Pay: $40 - $45 an hr.

Required Experience and Skills:

• Possesses an advanced knowledge and ability to operate information systems (SAP and Veeva Systems preferred) required to complete job responsibilities with the ability to generate data and reports from these systems.

• Must possess a minimum of three (3) years’ experience in a GMP pharmaceutical manufacturing facility with either direct involvement in Quality functions supporting release and compliance activities or indirect involvement in Quality functions through execution of activities such as batch record/documentation reviews, investigations, corrective actions, complaints, quality system management, etc.

• Must possess highly developed written and oral communication and teamwork skills.

• Strong attention to detail, problem-solving skills, and proficiency in time management.

• Identifies and solves a range of problems in straightforward situations and analyzes possible solutions using standard procedures.

• Flexible, multitasker, able to work under pressure, and adheres to project timelines.

• Ability to independently respond to advanced requests for data and trending and proactively utilizes data to improve operations or drive change.

Responsibilities:

The responsibilities of the Specialist, Quality Assurance include, but are not limited to:

• Support batch record management, retrieval, and generation of batch conformance documentation (CoC and CoA).

• Completion of batch record reviews for domestic market, intermediate, and finished product releases.

• Support site Quality-owned investigations, data compilation, and regulatory inspections.

• SOP development and review, Supplier Quality Management, and other Quality Assurance-related functions as required.

• Demonstrates strong leadership capability, critical thinking skills, and the ability to work independently to ensure timely completion of responsibilities.

• Knowledgeable in regulatory requirements and ensures site compliance with all expectations.

Additional Responsibilities May Include:

1. Batch record review and intermediate/finished product release activities for domestic distribution.

2. Provide Quality Assurance review and approval of GMP-related SOPs. Assist in the development of procedures to improve compliance status.

3. Defect resolution using statistical methods and control of material throughout the plant site.

4. Participate in plant investigation root cause analysis, corrective action identification, and recommendation of affected material disposition.

5. Ownership and completion of Quality-related investigations.

6. Participate in project and PCR strategy meetings supporting Quality Master Data builds and maintenance.

7. Support implementation of new programs, regulations, and divisional processes.

8. Identify and implement continuous improvement opportunities in business and compliance processes.

9. Maintain 5S organization and identify improvement opportunities.

10. Demonstrate leadership in maintaining a safe workplace and taking actions to prevent safety incidents.