FSP - QC Reviewer - Biologics Data Review

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards Laboratory Setting

Job Description

This is a fully onsite role based at our customers site in Foster City CA. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position and any relocation costs will be the responsibility of the candidate.

Must be legally authorized to work in the United States withoutsponsorship.

Must be able to pass a comprehensive background check whichincludes a drug screening.

At Thermo Fisher Scientific youll 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.

Thermo Fishers clinical research business is a leading global contract research organization and world leader in serving science. We are passionate deliberate and driven by our mission to enable our customers to make the world healthier safer and cleaner.

Our Laboratories Functional Service Partnership (FSP) team plays a direct role in advancing drug development by creating sustained groups of talent within our customers organizations to provide long-term support. Through this collaborative approach our professionals bring their commitment to excellence industry knowledge and operational strength directly into customer environments helping to enhance capabilities and advance the delivery of life-changing therapies.

Key responsibilities:

The QC Reviewer - Data Review is responsible for supporting Quality Control (QC) data review and governance activities for biologics products. This role ensures the accuracy completeness and compliance of analytical data and documentation generated by contract laboratories in support of product release stability method qualification method transfer validation and regulatory activities. The incumbent collaborates closely with external QC laboratories and cross-functional partners to identify and resolve data and documentation issues and maintain compliance with GMP requirements data integrity principles and quality systems.

• Perform data review and reporting activities supporting release stability qualification transfer and validation activities in accordance with approved procedures. Identify trends patterns or issues in the data and communicate findings to support timely review and approval activities.
• Identify and escalate discrepancies documentation issues and potential data integrity concerns.
• Support review metrics collection and data trending activities.
• Participate in document revisions process harmonization efforts and continuous improvement efforts.
• Support deviations investigations and CAPAs associated with data review and governance.
• Support regulatory submissions inspections and health authority responses through authoring QC data review technical assessments and preparation of supporting documentation.
• Perform QC data verification activities to ensure accuracy and completeness and compliance of records
• Demonstrate working knowledge of GMP requirements data integrity principles and quality systems.
• Collaborate effectively with QC leads laboratories and cross-functional partners

Education and Experience:

• Bachelors degree in lab sciences such as Chemistry Biochemistry Biology Pharmaceutical Sciences Chemical Engineering or similar
• Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 2-5 years)

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:

• Perform data review and reporting activities supporting release stability qualification transfer and validation activities in accordance with approved procedures. Identify trends patterns or issues in the data and communicate findings to support timely review and approval activities.
• Identify and escalate discrepancies documentation issues and potential data integrity concerns.
• Support review metrics collection and data trending activities.
• Participate in document revisions process harmonization efforts and continuous improvement efforts.
• Support deviations investigations and CAPAs associated with data review and governance.
• Support regulatory submissions inspections and health authority responses through authoring QC data review technical assessments and preparation of supporting documentation.
• Perform QC data verification activities to ensure accuracy and completeness and compliance of records
• Demonstrate working knowledge of GMP requirements data integrity principles and quality systems.
• Collaborate effectively with QC leads laboratories and cross-functional partners

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 $74000.00$79600.01.

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: ]]><