Quality Assurance / Technical Operations Specialist

Company Name:
Opus Scientific
Quality Assurance / Technical Quality Operations Specialist - Eastern Suffolk County, NY
Opus Scientific is looking to identify individuals for multiple excellent opportunities within Quality Assurance with progressive pharmaceutical company.
Responsibilities
Review and approve all technical documentation including Deviations, Complaint Investigations, and CAPA.
Review and approve all R & D protocols and reports, validation and qualification protocols and reports, and change control justifications.
Schedule, perform, report and make recommendations on internal and external quality audits.
Generate and review documentation associated with the Annual Product Review process.
Act as a liaison between QA and other departments on technical issues.
Identify quality process improvements to increase efficiencies and performance of systems, operations, and personnel.
Qualifications
Bachelors Degree in scientific discipline
2+ years experience in a pharmaceutical setting
Strong working knowledge of Federal (FDA) Good Manufacturing Practice (GMP) requirements, guidelines, and documentation practices
Excellent technical writing skills, strong oral and written communication skills
Salary
Commensurate with experience.
If you meet the qualifications and are interested in hearing more about this opportunity, please submit your resume to and include Quality Assurance Technical Quality Operations Specialist as the email subject line.

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