Quality Support
HTSS•Bethlehem, PA
18d•$18
About The Position
HTSS is seeking a Quality Support team member to assist with training programs, procedural documents, and the daily operation of our electronic Quality Management System. This role helps ensure compliance with cGMP standards and supports key Quality System activities. We will need support to help offset the workload on a temporary basis.
Requirements
- BA/BS in a scientific field preferred
- Bachelors’ Degree, Associates Degree, or equivalent in science related field accepted
- 4+ years of Quality Assurance/Quality Systems experience
- Knowledge of cGMP, Part 11 compliance, and pharmaceutical regulations
- Strong communication, organization, and computer skills
Nice To Haves
- Experience with Veeva or validated electronic QMS systems a plus
Responsibilities
- Support daily QualityOne system activities and user access management
- Track and manage Quality System records (NCRs, CAPAs, Change Controls)
- Assist with quality metrics, trending, document updates, and training
- Help prepare for inspections and audits (FDA, DEA, partner companies)
- Maintain quality records, retention, and documentation accuracy
- Participate in cross-functional projects and inspection readiness activities
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What This Job Offers
Job Type
Full-time
