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Quality Assurance Associate
Cook GroupQuality Assurance Associate I at Cook MyoSite ensuring compliance in quality processes and supporting cGMP operations. Responsibilities include documentation reviews and quality system management.
ATS Keywords
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Hard Skills
quality assurancedocumentation reviewbatch record creationlabel verificationinvestigation report writingdata entryrisk assessmentcustomer complaint managementGLPcGMP
Soft Skills
communicationorganizational skillsattention to detailteam collaborationproblem-solving
Tools & Technologies
Microsoft Officegeneral office equipment
Industry Keywords
good documentation practicesquality system documentscGMP operation activities
About the role
Key responsibilities & impact- Review and approve documentation associated with incoming biopsies.
- Review and approve documentation associated with incoming materials
- Review and approve records and associated data in support of cGMP operation activities.
- Create batch records, product labels and performs label verification processes.
- Perform quality reviews and approvals of batch records. Responsible for dispositioning batches.
- Participate in company projects as a quality representative.
- Participate in risk assessment activities.
- Perform investigation report writing, reviewing and closing investigation reports.
- Conduct and document training events.
- Management of customer complaints.
- Authoring quality system documents.
- Perform various office-related duties; filing, scanning, and data entry.
- Promote GLP/cGMP environment and follows procedural guidelines.
Requirements
What you’ll need- Undergraduate degree in any Life Sciences and 1-3 years’ relevant experience OR 6 years direct, relevant experience in Quality Assurance
- Minimum of 3 years' experience in Quality Assurance
- Proficient knowledge of Microsoft Office software, and other general office equipment.
- Knowledge of cGMP regulations and good documentation practices
Benefits
Comp & perks- Company pays for continuing education, training, and professional development
- Health insurance and wellness programs