Quality Specialist II

Quality Specialist II

Vacancy expired!

Responsibilities:

• Draft quality assurance procedures (such as SOPs) and provide support in driving the improvement programs in the Quality Assurance Team


• Review and approve of SOP's; provided consultation in development of new SOP's to ensure product development conforms with GXPs


• Perform audits, internal and external CMOs, laboratories, vendors

Perform investigations, review and implement CAPAs

• Support for Manufacturing Projects including review of all manufacturing related support documentation and forms after the batch is complete


• Issuance and control of Logbooks for Manufacturing and QC Department

Backup for all otherQA functions


• Review and approval of QC data


• Backup administrator for eQMS system (MasterControl preferred) and provide support for ongoing maintenance and training to end users.


• Maintain Document Management System including storage, and archival of all GMP documents

Requirements:

• 4 year science related degree in chemistry, microbiology, biochemistry or biology preferred.


• Strong proven analytical/problem solving skills preferred


• Excellent computer skills; experience with database programming a plus

High integrity and sense of responsibility, detail oriented, willing to work with little or no supervision
Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies

• Ability to adhere to Good Documentation Practices within a cGMP environment

Keen attention to detail and adherence to Standard Operating Procedures

• Ability to excel in a fast-paced work environment


• Ability to lift 50lb


• Ability to multi-task and be flexible with changing priorities

Position is full-time, Monday-Friday, 8:30 a.m.-5 p.m., with overtime as needed

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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