QC Sample Management Sr. Site Specialist

Location/Division Specific Information

This position is located in Thousand Oaks, CA. This position is a Tuesday to Saturday shift, with Sundays and Mondays off.

How do we make an impact?

Unity Lab Services provides a single source for integrated lab service, support, and supply management. Our customized service offerings and world-class service experts have the flexibility and experience to uniquely address our customer’s laboratory's business needs.

What will you do?

• Manage client's sample material which may include doing daily courier runs for pick-ups, label samples, prep for incoming and outgoing shipments, log samples, run customer service window, and regular inventory management in labs.
• Manage stability study activation process.
• May be required to come on site after hours to perform time point study pulls
• Manage critical temperature control chambers, including after-hours cell phone coverage on a mandatory rotational basis
• Deliver on committed contractual scope of work.
• Assist with tracking business metrics, inbox monitoring and responses, work order closures, etc. per service level agreements.
• Follow SOPs, work instructions, all safety procedures, and established quality processes with consistency and precision.
• Prepare for site audits, and use client computer systems to track work.
• Follow Good Documentation Practices in all record keeping
• Drive process improvement culture by supporting Practical Process Improvement (PPI) initiatives.
• Represent Thermo Fisher Scientific at all times throughout customer locations, professionally and positively.
• May perform other responsibilities as assigned by management.

How will you get here?

Education

High school diploma or equivalent required. Associate's or Bachelor's degree in Life Sciences, Biology, Chemistry, Microbiology, Biochemistry, Engineering, Pharmaceutical Sciences, Food Science, or a related technical field preferred. Equivalent combination of education and relevant experience in a GMP or other regulated environment may be considered in lieu of a degree.

Experience

2+ years within a quality setting or regulated environment. GxP experience is preferred.

Knowledge, Skills, Abilities

• Demonstrated knowledge of quality systems, quality assurance, and/or quality control principles, with the ability to apply them in a manufacturing or laboratory environment.
• Experience working in a Good Manufacturing Practice (GMP) and/or other regulated environment (e.g., FDA, ISO, cGMP), with a strong understanding of compliance requirements and documentation standards.
• Strong attention to detail with the ability to accurately review, document, and verify information while maintaining a high level of quality and accuracy.
• Strong verbal and written communication skills. This includes maintaining a professional appearance and demeanor in all interactions and upholding Thermo Fisher Scientific's values, including confidentiality.
• Proficiency with Microsoft Office Suite and experience using electronic quality management systems (eQMS), ERP systems, or other regulated documentation systems is preferred.
• Possesses strong analytical abilities to problem solve, make timely decisions, re-balance staff workloads, and coordinate multiple overlapping priorities, while functioning in a fast-paced work environment.

Physical Requirements / Work Environment

• Works primarily at customer site, which may require independent work at the customer locations.
• Work areas may include spaces where chemical-based allergens are in use (such as penicillin, tetracycline, etc)
• Work a Tuesday to Saturday schedule, with Sundays and Mondays off.
• Depending on the area of the building, personal protective equipment may be worn, including lab coats, safety gloves, safety shoes, and/or safety glasses.
• Requires the ability to lift, push, and pull 30-40 pounds consistently; may be required to lift 50 pounds occasionally, including operation and use of pushcarts, pallet jacks, etc.
• Regularly required to stand or walk for prolonged periods.
• Ability to work overtime, as needed.