FSP - QC Reviewer

Regulatory Toolkit; Foster City (CA); On-site; USD 68,000 - 80,000; Full time

Benefits offered by this job

Annual bonus

Healthcare

Stock Purchase Plan

PTO & Holidays

Job summary

Thermo Fisher Scientific is seeking a QC Reviewer to join our Analytical Services team onsite in Foster City, CA. You will review data, verify numerical details for regulatory filings, transcribe SOPs, and update administrative records while contributing to QC metrics and continuous improvement.

The role requires a Bachelor's in lab sciences (or a Master's) and 2+ years of related experience with strong GLP/GMP knowledge. Onsite collaboration with laboratory staff is essential.

Qualifications

• Bachelor's degree in lab sciences or related field.
• 2+ years of relevant experience or a Masters degree.
• Strong knowledge of GLP and GMP standards.

Responsibilities

• Review raw data for accuracy and completeness.
• Perform numerical data verification for regulatory filings.
• Transcribe SOPs and update records.
• Consolidate data for QC metrics and reports.
• Train new QC reviewers and staff.

Skills

Attention to detail

Data verification

SOP knowledge

Regulatory compliance

Education

Bachelor's degree in lab sciences

Masters degree

Tools

GLP/GMP knowledge

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

QC REVIEWER:

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

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.

This role is based onsite in: Foster City, CA

Key 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.

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

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

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

Working Environment:

• Below is listed the working environment/requirements for this role:
• 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!

Compensation and Benefits

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

• Retirement 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