Quality Assurance Specialist, I
$60,008–$70,720 year
On-siteBurlington, Massachusetts, United States
Job Summary
Conduct batch record reviews, media disposition, label issuance, archiving, and final product packaging and release activities within required SOP timeframes. Perform inspections of final product in ISO 7 clean room areas and verify procedures for intermediate and final product release. Support day-to-day operations, revise Standard Operating Procedures, and identify deficiencies to remedy them with cross-functional departments. Provide recommendations for process improvements and support projects as a QA resource. Complete initial onsite training in Burlington, MA, followed by a rotating schedule of Tuesday–Saturday or Sunday–Thursday.
Required Qualifications
- High School degree/GED with 2 years of relevant pharmaceutical/biotech experience
- Bachelors plus 0-1 years of relevant pharmaceutical/biotech experience
- Basic working knowledge of GMP regulations
- Ability to lift and transport up to 30 lbs
- Must be able to work one weekend day
- Must be able to support rotating holiday coverage
- Must be able to gown into classified manufacturing ISO 7 clean room areas, to conduct inspection of final product
- Must be able to gown into CNC areas
Desired Qualifications
- Strong written and verbal communication skills
- Strong organization and time management skills
- Proficient in MS Word and Excel
- Experience with electronic batch records, ERP systems and Quality Management Systems (Examples: TrackWise and Veeva)
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