- 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.
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Quality Specialist - Elkton, United States - Pyramid Consulting
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Description
Immediate need for a talented Quality Specialist - I (Assistant). This is a 12+ Months Contract opportunity with long-term potential and is located in Elkton, VA (Onsite). Please review the job description below and contact me ASAP if you are interested.
Job ID:
Pay Range: $35 - $39/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
Our client is a leading PharmaceuticalIndustry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.