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Quality Specialist - Elkton, United States - Talent Software Services
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
