Sr. Quality Control (QC) Specialist

Planet Group; Santa Monica (CA); Vor Ort; USD 69.000 - 74.000; Vollzeit

Zusammenfassung

Planet Group is seeking a Sr. Quality Control (QC) Specialist for an onsite role in California. The position is a 5-month contract with an initial on-site period in Santa Monica, some remote time, and a return to Thousand Oaks.

Responsibilities include data extraction from LIMs, execution of reporting programs, and coordination of continuous improvement with site teams. Proficiency in JMP/Minitab and strong regulatory knowledge (21 CFR Part 11/210/211) are required.

Qualifikationen

• Master's or Bachelor's degree with 4+ or 6+ years in a Quality function in pharma/biotech
• Experience aligned with 21 CFR Part 11/210/211, GMPs, GLP
• Strong data reporting, analysis and QA documentation skills

Aufgaben

• Execute global reporting control and invalid trending programs.
• Extract data from LIMs to support reporting needs.
• Lead continuous improvement activities with sites.
• Author Annual Product Review Laboratory Section and quarterly reports.
• Support new methods, KLIMS implementation, and new capabilities.

Kenntnisse

Statistical analysis

Documentation & reporting

Regulatory knowledge

Ausbildung

Master's Degree in related field

Bachelor's Degree in related field

High School diploma

Tools

JMP

Minitab

Jobbeschreibung

Sr. Quality Control (QC) Specialist

Pay: $50- $53.96per hour

Duration: 5months

Location: Onsite (initially in Santa Monica for the month of November, some remote time, then return to office in Thousand Oaks)

Responsibilities (include but are not limited to):

• Execute global reporting control and invalid trending programs.
• Execute data extraction from LIMs system to support reporting requirements.
• Lead/coordinate continuous improvement activities partnering with sites.
• Author Annual Product Review Laboratory Section.
• Author technical quarterly invalid and biannual control trending reports.
• Interact with the laboratory operations group to support new methods, technology, and KLIMS implementation and ongoing support for new module implementations and/or installation of new capabilities.
• Meet reporting deadlines as defined per procedure demonstrating organizational, prioritization, and time management proficiencies.
• Highly effective written and oral communication skills to address a cross-functional audience.
• Self-motivated, detail-oriented, and willingness to support other team members.
• Improve processes to minimize complexities and optimize operational effectiveness.
• Proficient with statistical tools such as JMP and/or Minitab.
• Proficient in Microsoft Office application.
• Working knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211), Quality Control, GMPs, GLP.

Basic Qualifications:

• Master's Degree and 4+ years' experience in a Quality function in the pharmaceutical or biotechnology industry
• OR Bachelor's Degree and 6+ years' experience in a Quality function in the pharmaceutical or biotechnology industry
• OR High School Degree and 10+ years' experience in a Quality function in the pharmaceutical or biotechnology industry.

Preferred Qualifications:

• Experience with gene and cell therapies or pharmaceutical industry, Statistical knowledge in biologics is a plus.
• Able to adjust workload based upon changing priorities.
• Experience in Risk Management processes a plus.
• Experience with US and international health authority inspections a plus.