Job Type: Full-time
Salary: $75,000.00 to $95,000.00 /hour
Quality Assurance Associates will participate in the generation, review, approval and training in support of cGMP quality systems and will be responsible for Quality Assurance activities in one or more suites for manufacturing operations.
- Develop, review, approve and/or maintain documents that support both Quality Assurance and Operations. This may include Batch Records, Protocols and Reports (Engineering, Validation, Qualification, Stability, etc.), Risk Assessments, Process Flow Diagrams, Standard Operating Procedures (SOP's), Investigations, and any other technical documents as required.
- Lead/represent QA on project teams in support of new product and manufacturing activities.
- Review and approve incoming materials including but not limited to active pharmaceutical materials, excipients, components, and packaging materials.
- Perform Quality oversight during manufacturing operations, including identifying and implementing process improvements through change control, investigations of non-conforming material, equipment, processes, etc., and review of the manufacturing documentation (batch records, logbooks, analytical testing data, protocol(s), etc.)
- Perform review and approval of executed documents.
- Assist in the identification, action, and resolution of changes and issues during manufacturing activities.
- Develop and implement SOPs specifically related to CGMP quality systems, operations, and the facility, including training and training file maintenance.
- Assist in management of quality systems on a company-wide basis, including document control, vendor quality, training, CAPA, change management, auditing, validation/qualification programs, and non-conformance investigations.
- 3+ yeras of experience working as a quality assurance associate
- Strong work ethic and ability to accomplish tasks without supervision
- Quality/CGMP experience in the pharmaceutical industry
- Exhibits leadership, both by work and example,
- Strong organizational skills and the ability to focus on multiple projects in a fast-paced
- Knowledge of CGMP and regulatory principles,
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