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location: Marietta, Pennsylvania
job type: Contract
salary: $37.29 - 43.88 per hour
work hours: 9 to 5
The QA Systems Specialist is responsible for the oversight, monitoring, and reporting function to support quality systems that are used at Marietta facility to support production of vaccines. The Quality systems under the scope of this role include deviation system, change management system, CAPA system, customer complaints, Product Quality review, & Quality Management system. The QA Systems Specialist is responsible to ensure compliance with internal procedures, policies, standards and industry regulations.
- Responsible for quality system process expertise and daily oversight activities for cGMP quality systems.
- Responsible for ensuring the Quality Systems LSOP/processes are robust and compliant with regulatory and global requirements.
- Responsible for reporting and monitoring on cGMP quality systems, site KPIs, and other miscellaneous quality unit systems.
- Responsible for execution of training activities on cGMP quality Systems (Qualified Trainer).
- Responsible for acting as QA liaison with QA operations to site personnel to resolve technical problems or provide quality system expertise to help provide solutions while still assuring compliance to cGMP.
- Responsible for backup roles for documentation systems responsibilities within the quality systems disciplines (includes; procedures management, documentation control, archival & logbooks).
- Complete all work with highest regard to quality and safety by ensuring compliance with GMPs, applicable EHS regulations, standard operating procedures, and industry practices.
Education & Qualifications:
BA/BS degree in sciences or business. Degree in other discipline if sufficient technical depth has been achieved by professional experience (Biology, Microbiology, Chemistry, Biochemistry, Business, Statistics)
- 3-5 years pharmaceutical experience in a Quality Organization is preferable.
- Experience working with technical writing for data trending and trend reporting
- Strong communication and problem solving skills with the ability to listen to others and evaluate and communicate solutions
- Demonstrated ability to work well with and influence others without direct reporting relationships, ability to work with a team
- SAP Experience preferred
skills: CAPA, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.