Deviation Investigator at THERMO FISHER BIOPHARMA SERVICES PTE LTD

Berkeley, Missouri, United States -

Full Time

Start Date

Immediate

Expiry Date

01 Apr, 26

Salary

0.0

Posted On

01 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GMP Compliance, Root Cause Analysis, CAPA Development, Technical Writing, Analytical Skills, Problem-Solving, Communication Skills, Project Management, Quality Management Systems, Team Collaboration, Regulatory Compliance, Internal Audits, Microsoft Office, PPE Knowledge, Deviation Investigations, Change Control

Industry

Biotechnology Research

Description

Work Schedule First Shift (Days) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description How will you make an impact? Join Thermo Fisher Scientific as a Quality Specialist II and contribute to global healthcare and scientific advancement. In this role, you'll ensure compliance with GMP standards, FDA regulations, and international quality requirements while supporting manufacturing operations across multiple product lines. Working with cross-functional teams, you'll implement continuous improvement initiatives, conduct investigations, and maintain quality management systems A day in the Life: · Manage Major deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings. · Drive improvements to the investigation process. · Present investigations to regulatory inspectors, internal auditors, and management. · Clearly communicate investigation progress to impacted areas and leadership. · Coordinate and effectively lead cross-functional teams through complex investigations, and complete milestones on-schedule. · Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues. · Document findings in a comprehensive and objective manner, ensuring accurate recording of all relevant information. · Ensure timely completion of investigations. · Collaborate with cross-functional teams, including manufacturing, quality assurance, process engineering, and regulatory affairs, to gather information, evaluate causal factors, and implement corrective and preventive actions (CAPAs). · Regularly adapts standard Root Cause Analysis methods and techniques to unique investigations, using expertise to select the best-in-class approach. · Provide timely written documentation of investigations and communicate recommendations based on investigation outcomes. · Participate in client communications and responses, working closely with program team leads, quality, and management. · Continuously improve investigation processes and tools to enhance efficiency and effectiveness. · Mentor junior employees on performing investigations, root cause analysis, and identifying effective CAPAs. that enable our mission of making the world healthier, cleaner, and safer. Keys to Success: • Advanced degree with no prior experience, or Bachelor's degree with 2 years of experience in pharmaceutical/biotech manufacturing, quality assurance, or related GMP environment preferred • Preferred Fields of Study: Biology, Chemistry, Engineering, Life Sciences, or related scientific field • Knowledge of cGMP regulations, ISO standards (9001/13485), and international regulatory requirements • Experience with quality management systems and documentation (TrackWise, Master Control, or equivalent) • Experience in deviation investigations, CAPA, change control, and root cause analysis • Proficient in Microsoft Office suite and quality management software systems • Technical writing and documentation skills • Analytical and problem-solving abilities • Clear verbal and written communication skills • Ability to work independently and collaboratively in cross-functional teams • Experience conducting internal audits and supporting external regulatory inspections • Project management and organizational skills • Ability to work in cleanroom environments and follow gowning procedures where required • Additional language skills may be beneficial • Up to 10% travel may be required • Must be able to work various shifts to support manufacturing operations • Physical requirements include standing/walking for extended periods and occasional lifting up to 25 lbs Excellent Benefits Benefits & Total Rewards | Thermo Fisher Scientific Medical, Dental, & Vision benefits-effective Day 1 Paid Time Off & Designated Paid Holidays Retirement Savings Plan Tuition Reimbursement OTHER Relocation assistance is NOT provided Must be legally authorized to work in the United States now or in the future, without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening

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Responsibilities

Manage major deviation investigations and lead root cause analysis while ensuring compliance with GMP standards. Collaborate with cross-functional teams to implement corrective and preventive actions and document findings comprehensively.