Quality Specialist - Elkton, United States - TALENT Software Services

TALENT Software Services Elkton, United States

6 days ago

Pharmaceutical / Bio-tech

Description

Are you an experienced Quality Specialist with a desire to excel? If so, then Talent Software Services may have the job for you Our client is seeking an experienced Quality Specialist to work in Elkton, VA.

Position Summary: At the client's campus in Elkton, Virginia, we have a Specialist Quality Assurance position available on our Quality Team. The manufacturing facility is located in the Shenandoah Valley along the Shenandoah River and the Blue Ridge Mountains a short distance from the University of Virginia and James Madison University. The successful candidate will have the opportunity to apply their enthusiasm and skills as a member of a multidisciplinary team supporting the operation of vaccine product manufacturing facilities.

Primary Responsibilities/Accountabilities:

• Providing Quality support for vaccine, biologic, and sterile manufacturing processes through collaboration with Technical Operations and Operations.

• Performing review and approval for investigations, corrective and preventative actions, regulatory commitments, change requests, risk assessments, validation protocols, master batch records and standard operating procedures.

• Provide Quality guidance and assistance in deviation identification and initiation.

• Perform review of batch records and documentation

• Actively participates in site inspections/audits by facilitating discussions with inspectors/auditors, fulfilling requests for information, and presenting to inspectors on required topics as Quality representative.

• Supports the preparation of regulatory filings.

• Write, review, approve standard operating procedures and other instructional documents for shop floor.

• Provides training to incoming personnel and ensures compliance with departmental procedures.

Qualifications:

• Bachelor's degree in a science discipline (biology, chemistry, engineering, other) or related scientific field and a minimum of two (2) year's experience in Pharmaceutical, Manufacturing, Maintenance or Military environments or GMP.

• OR Master's degree with minimum of 1 year experience in Pharmaceutical, Manufacturing, Maintenance or Military environments or GMP.

• Strong verbal and written communication skills, team skills, personal character, and ethics

• Strong problem-solving skills and a hands-on approach to problem solving, with a bias towards going to see problems for oneself in the field.

• Ability to examine an issue from diverse perspectives (safety, compliance, maintenance, automation, equipment, process, and people) in order to best understand and resolve it.

• Enthusiasm, confidence, and initiative-taking ability needed for continuous learning and its applications.

• Strong desire to succeed and to help others to do the same.

• Demonstrated verbal/written communication and decision-making skills.

• MS office suite (word,outlook,excel,powerpoint)

• SAP

• Electronic batch record system(MES)

• Delta V system

Preferred:

• Deviation management experience

• Experience in vaccines manufacturing

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