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Thermo Fisher Scientific · 5 days ago

Sr QC Reviewer, LIMS Data Entry/Review

Foster City, CA

Full-time

Onsite

Mid, Senior Level

$82K/yr - $93K/yr

4+ years exp

Thermo Fisher Scientific is a company that enables customers to make the world healthier, cleaner and safer. The Sr QC Reviewer will perform data entry and review in LIMS to ensure GMP compliance and provide audit support, while also conducting analytical data reviews and managing time effectively to meet deadlines.

BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine

No H1B

Responsibilities

Perform data entry and data review in LIMS in accordance with Work Instructions to ensure GMP compliance

Provide audit support as needed

Troubleshoot issues related to Certificates of Analysis and Stability Reports

Conduct complex analytical data reviews, evaluating laboratory data for compliance with analytical methods, SOPs, directives, and scientific integrity

Manage time effectively to ensure timely delivery of all assignments

Demonstrate strong communication skills and proactively engage to ensure effective collaboration

Adhere to GMP requirements for all training programs

Performs complex analytical data review, evaluating laboratory data for compliance with analytical methods, SOPs, directives and scientific soundness

Reviews sample results for completeness and accurate representation of the data and reports findings

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

Assists the departmental manager or supervisor in the evaluation of the laboratory QC program

Performs other duties as assigned

Qualification

LIMS data entryGMP complianceAnalytical data reviewSOP knowledgeChromatographyLaboratory proceduresStaff trainingCommunicationAttention to detailCollaborative teamwork

Required

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

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 4+ years') OR Masters degree and 2+ years of above related experience

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

Benefits

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