PCI Pharma Services
QC Specialist II, Analytical Investigations
Job Description
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.
**What You’ll Do**
**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 shap...
**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.
**What You’ll Do**
**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 shap...