Spclst, Quality Assurance
Merck
Full-time
Remote friendly (Durham, NC)
United States
$85,600 - $134,800 USD yearly
Operations
Want to see how your resume matches up to this job? A free trial of our JobsAI will help! With over 2,000 biopharma executives loving it, we think you will too! Try it now — JobsAI.
Role Summary
Quality Assurance Specialist
Responsibilities
- Executes critical site review and review of environmental monitoring data.
- Perform review of batch records and documentation.
- Perform review of process simulation batch records.
- Perform data review and run reconciliation activities as required (i.e., UV and FIT testing).
- Perform Quality retain sample management activities.
- Lead housekeeping and self-inspections.
- May approve incidents and investigation related to deviation management.
- Assists cross-functional team with executing and approving change controls.
- Approve cleaning validation documentation as needed.
- Learn new processes and procedures.
- Perform shift work as needed.
- May act as a Quality Risk Assessment Lead.
Qualifications
- High School Diploma or equivalent
- Minimum four (4) years’ experience in Manufacturing, Maintenance, Laboratory or Military environments.
- including two (2) years’ experience in an GMP or FDA regulated industry.
Skills
- Demonstrated interpersonal skills including flexibility and collaboration
- Demonstrated analytical aptitude, critical thinking skills, and problem solving
- Demonstrated ability to upskill others
- Demonstrated verbal and written communication skills
- Experience in pharmaceutical related environment
Education
- Not specified in provided content
Additional Requirements
- Travel Requirements: 10%