Sr. Specialist, Quality Control Raw Materials

Here's What You'll Do

• Oversight of prioritization and release of raw materials to meet metrics and turnaround times.
• Review of Raw Data, supplier certification and incoming documentation to meet requirements.
• Specification review and approval.
• Support Continuous Improvement of lab operations.
• Project management and execution to deliverables and timelines.
• Audit support during Regulatory and Health Authority Inspections.
• Requesting, sampling, releasing, and shipping of raw materials.
• Sample coordination including cross functional collaboration with internal and external labs.
• Train and perform testing for methods including HPLC, Bioanalyzer, osmolality, pH, conductivity, TruScan, RM spectroscopy, appearance, and dimensional verification.
• Supporting domestic and international sample shipments.
• Inspect product and raw material retain samples.
• LIMS (LabVantage) sample logging and result entry.
• Raw material and consumable component inspection and release.
• Controlled temperature unit management, maintenance, and troubleshooting.
• Clean room gowning and aseptic techniques.
• Write/revise SOPs, protocols, and reports.
• Complete and maintain cGMP documentation for work performed.
• Participate in authoring quality systems records such as deviations, change controls, CAPAs.
• Lead laboratory investigations and deviations as required.
• Conduct and lead risk assessments.
• QC Management designee for QC inspection label issuance and reconciliation.
• Establish and maintain a safe laboratory working environment.
• Foster a positive and inclusive work culture that promotes collaboration, innovation, and continuous improvement.
• Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
• Execute tasks precisely as defined in internal guiding documents including, but not limited to, standard operating procedures (SOPs) and work instructions.
• Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
• Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.

Here's What You'll Bring to the Table (Basic Qualifications)

• Education: BS in a relevant scientific discipline.
• Experience: 6+ years with BS or 8+ experience in GMP QC laboratory setting.
• Demonstrated aptitude or ability to learn: Demonstrate strong understanding of GxP Regulations and Problem Solving.