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QA Specialist I (Biotech/Pharma)Contract: Frederick , Maryland, US
Salary: $32.00 Per Hour
Job Code: 348232
End Date: 2024-05-15
Days Left: 21 days, 3 hours left
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To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - email your updated resume at Email - ...@collabera.com or give me a call at (425) ###-####. Thank you! Job Description:Job Roles & Responsibilities:Knowledge:
- Demonstrates basic knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
- Demonstrates basic knowledge of FDA / EMEA standards and quality systems.
- Demonstrates good verbal, written, and interpersonal communication skills.
- Demonstrates working knowledge in MS Office applications.
- Specific Education & Experience Requirements:
- 2+ years of relevant experience in a GMP environment-related field and a BS.
- 3+ years of relevant experience and an AA degree.
- Prior experience in regulated industry is required.
- Pharmaceutical industry experience is beneficial.
Specific Job Responsibilities: - Performs a variety of activities to ensure compliance with applicable regulatory requirements.
- Maintains programs and processes to ensure high-quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
- Supports site Quality Systems programs (Deviation, CAPA, CC, etc...)
- Works with operating entities with guidance from senior colleagues to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
- May support root cause analysis investigations and corrective actions
- Provides visibility on key site metrics to site leadership and escalation issues as needed.
- Normally receives general instruction on routine work, detailed instructions on new assignments.
Job Requirement - QA Specialist
- Quality Assurance
- Quality Control
- CAPA
- deviation
- Deviation
- GMP
- GLPs
- FDA
- EMEA
- Biotechnology
- Pharma
- Pharmaceuticals
- Good Manufacturing Practices
Reach Out to a Recruiter - Recruiter
- Email
- Phone
- Chitrank Rastogi
- ...@collabera.com
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