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Quality Control Inspector
3 months ago
Responsibilities:
- Learn SOPs, safety procedures, and QC methods.
- Assist with IQ/OQ/PQ of new equipment; collaborate with field engineers.
- Draft/review SOPs, forms, FMECA, tech transfer protocols, and validation protocols.
- Perform QC testing for batch release within hours of production.
- Continue Setup Phase tasks; adhere to SOPs, cGMP, and regulatory requirements.
- Follow EHS regulations, including NRC, OSHA, and EPA guidelines.
- Maintain readiness for inspections and ensure qualification for all QC procedures.
- Verify instrument calibration/qualification.
- Confirm raw materials are not expired and perform system suitability testing.
- Conduct QC testing for chemistry, microbial, EM, and sterility.
- Complete and review documentation; troubleshoot equipment and report issues.
- Assist with material handling, QC lab maintenance, waste disposal, and employee training.
- Draft/review SOPs, assist with quality events, and support equipment qualification/method validation as needed.
Qualifications:
- Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related discipline.
- Minimum of 2 years in Quality Control, including at least 1 year working with 21 CFR Parts 11, 210, and 211.
- Proficient with analytical instruments, HPLC, USP methods, ICH guidelines, and GMP practices.
- Solid grasp of GMP, FDA, and regulatory standards.
- Demonstrates high integrity and honesty, with a strong adherence to rules, policies, and regulations.
- Capable of managing multiple tasks effectively under pressure and tight deadlines.
- Detail-oriented with excellent organizational skills.
- Ability to stand for extended periods (6+ hours).
