Senior QC Reviewer
Thermo Fisher Scientific
Boston, Massachusetts, USAPosted 25 days agoDiscoveredMatch locked
On-siteFull time2+ years exp
Work Schedule
First Shift (Days)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting
Senior QC Reviewer
Position:
Shift: Full-Time; Monday - Friday; 8am-5pm EST
ONSITE
This is a fully onsite role based at our customer's site in
(Boston, MA).
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 without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.
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.
Thermo Fisher's 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
- Performs complex analytical data review, evaluating laboratory data for Functions
About the role
- 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
- Previous experience that provides the knowledge, skills, and abilities to perform the job
(comparable to 2+ 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
- 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 result
- Ability to work in a collaborative team environment
- undefined
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 poundsAble to work in non-traditional work environments.Able to use and learn standard office equipment and technology withproficiency.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.BenefitsWe 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 Massachusetts is $90,000.00-$95,100.00. 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
Not included in the source posting: about the role.
Who can apply
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