QC Specialist II, Analytical Investigations

Responsibilities

• As a QC Specialist, you will:
• Lead investigations into QC Analytical deviations, OOS/OOT/OOE results, and other quality issues.
• Serve as a key point of contact during audits and inspections, ensuring timely and compliant responses.
• Draft and revise change controls, technical reports, cGMP documents, and protocols.
• Perform QC analytical testing, review data, and identify trends to proactively address risks.
• Assist in managing analytical equipment to maintain compliance and efficiency.
• Collaborate cross-functionally to close out quality events and audit findings on time.
• Help shape and refine QC processes that support continuous improvement.
• What You Bring
• Education/Experience: Bachelor's degree in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or related field; 2-5 years of QC Analytical Chemistry experience (pharma experience preferred).
• Technical Skills: Hands-on experience with UPLC, HPLC, GC, FTIR, UV/VIS, Karl Fisher, Particle Size Analyzer, Densitometer, and Osmometer.
• Knowledge: Solid understanding of cGMP, ICH, USP, and global compendia guidelines, especially in analytical method validation and stability studies.
• Strengths: Strong organizational and documentation skills, technical writing ability, and excellent communication skills (written and verbal).
• Mindset: Ability to thrive in a fast-paced, dynamic environment, juggling multiple priorities while maintaining a sharp eye for detail.
• Tech: Proficiency in MS Office; experience with lab-based data management systems a plus.
• Why Join Us
• Be part of a collaborative team where your expertise directly impacts patient safety and product quality.
• Gain exposure to diverse analytical techniques and regulatory processes.
• Opportunity to work in a GMP environment supporting both clinical and commercial product lifecycles.
• Professional growth through hands-on problem solving, cross-functional collaboration, and continuous learning.
• #LI-LL1
• Join us and be part of building the bridge between life changing therapies and patients. Let's talk future
• Equal Employment Opportunity (EEO) Statement:

Benefits

Additional Information

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

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Company Intel

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