JOB DESCRIPTION

Sr QC Reviewer:
Job Description
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 will be onsite in: Foster City, CA

Key responsibilities:

• QC Scheduling and tracking of program deliverables
• manage program
• manage protocol and report completions
• Sample logistics
• Testing completion
• Stability set down
• Raw Material (Global)
• Specification creation
• Work with Change Controls for raw materials
• Performs complex analytical data review, evaluating laboratory data for compliance with analytical methods, SOPs, directives and scientific soundness.
• Validates large and/or non-routine projects. Performs analytical data review of method qualification and validation interpreting data for compliance and technical soundness.
• Reviews sample results for completeness and accurate representation of the data and reports 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.
• Assists the departmental manager or supervisor in the evaluation of the laboratory QC program.
• 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
• 4 years + Previous experience that provides the knowledge, skills, and abilities to perform the job OR Masters degree and 2+ years of above related experience

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!

• QC Scheduling and tracking of program deliverables
• manage program
• manage protocol and report completions
• Sample logistics
• Testing completion
• Stability set down
• Raw Material (Global)
• Specification creation
• Work with Change Controls for raw materials
• Performs complex analytical data review, evaluating laboratory data for compliance with analytical methods, SOPs, directives and scientific soundness.
• Validates large and/or non-routine projects. Performs analytical data review of method qualification and validation interpreting data for compliance and technical soundness.
• Reviews sample results for completeness and accurate representation of the data and reports 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.
• Assists the departmental manager or supervisor in the evaluation of the laboratory QC program.
• Performs other duties as assigned