Quality Control Analyst

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.
• 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).