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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Assurance processes, including documentation, compliance, and product release, while effectively communicating and coordinating with team members. Proficient in applying technical knowledge to medium-complexity assignments and ensuring adherence to cGMP standards.
Highest-signal resume keywords
QA Work ExperienceExperience Reviewing BPRsBS/BA Degree in STEMKnowledge of cGMPExcellent Communication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Technical SupportData AnalysisProblem ResolutionQuality Systems AdministrationChange ControlDiscrepancy ManagementBatch ReleaseDocumentationValidation ProjectsRegulatory Submissions
Soft Skills
Excellent Organizational SkillsDetail OrientedVery Efficient
Tools & Technologies
SAPSAP Quality Module
Industry Keywords
CGMPQuality AssuranceClinical StudiesStability StudiesAnnual Product Reviews
About the role
Key responsibilities & impact- Provide routine technical support for documentation, training, compliance, product release, scheduling, assignments, and projects
- Collect, review, and potentially analyze data
- Make decisions within a well-defined area
- Address and resolve problems according to written procedures or practice
- Coordinate work assignments and training of other employees
- Develop alternative solutions to problems
- Apply technical knowledge and expertise to medium-complexity assignments
- Perform roles such as author, reviewer, administrator, or coordinator in quality systems including Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, and Annual Product Reviews
- Provide Quality input for validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and regulatory submissions
- Represent Quality at the business unit
- Communicate effectively at all levels while supporting department objectives and management decisions
Requirements
What you’ll need- QA work experience
- Experience reviewing BPRs
- Excellent organizational skills
- Excellent communication skills
- Detail oriented
- Very efficient
- QA II: BS/BA degree preferably in STEM and minimum 2 years of related experience, or equivalent combination of education and experience
- QA III: BS/BA degree preferably in STEM and minimum 3 years of relevant experience, or equivalent combination of education and experience
- Ability to follow cGMP and department safety practices
Benefits
Comp & perks- Regular full-time employment
- Day shift schedule
