Quality Specialist - I (Assistant)
Job Title:
Quality Specialist - I (Assistant)
Job Location:
Elkton, VA
Job Duration:
12
months
Job Description:
The individual carries out a variety of activities to support manufacturing operations becoming familiar with site processes, procedures, and policies as individual develops knowledge aligned with cGMPs and Health Authority regulations.
The role will support the review and approval of qualification activities, change controls, batch records, auxiliary forms, investigations, procedures, and other quality related documentation.
The successful candidate will support aseptic operations on shift, including auditing of classified (Grades A/B/C) areas which also includes getting certified for Grade A/B gowning. May perform quarantine functions and accountability reviews.
Supports special projects as assigned. The role follows cGMP and routinely makes decisions using cGMP/process knowledge.
May work with customers to resolve problems and to satisfy quality and production needs. Follows site safety requirements.
Authors, reviews, and approves data/ documents such as methods, procedures, and/ or protocols. Performs all work and completes assignments in a timely manner and is an active member of 1 or more teams.
The individual tracks/reports metrics as needed. May provide training/ presentations as needed. May help with regulatory inspections.
Estimated Salary: $20 to $28 per hour based on qualifications.
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