FSP - QC Reviewer

About the role

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

Responsibilities

• Review raw data
• Numerical data verification for regulatory filings
• Transcribe SOPs
• Perform administrative updates
• Consolidate data for QC metrics
• Author clinical and commercial stability protocols
• Evaluates laboratory data for compliance with analytical methods and SOPs
• Reviews sample results for completeness and accurate representation of the data and report findings
• Communicates with laboratory staff to proactively address the quality of laboratory documentation
• Prepares QC statements noting deficiencies with the analytical data set or notebooks
• Reports deficiencies to the project leader for correction
• Trains new QC Reviewers and laboratory staff
• Conducts SOP review and writing
• Conducts consultations for quality records
• Performs other duties as assigned

Requirements

Education and Experience:

• Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
• 2+ years of previous experience that provides the knowledge, skills, and abilities to perform the job OR Masters degree

Knowledge, Skills and Abilities:

• Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP
• Thorough knowledge of chromatography and divisional SOPs
• Strong technical knowledge including an understanding of laboratory procedures, methodology and standards
• Strong verbal and written communication skills
• Strong attention to detail
• Ability to train staff
• Ability to independently review laboratory reports and analytical methods
• Ability to deal with multiple and changing priorities
• Ability to provide clear and concise feedback and/or documentation of results
• Ability to work in a collaborative team environment

Environmental Conditions

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary and/or standing for typical working hours.

Able to lift and move objects up to 25 pounds.

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and technology with proficiency.

May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.

Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects.

We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

The salary range estimated for this position based in California is $67,699.00–$80,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.

We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retail and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards