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Immatics · 1 day ago

Senior Quality Control Analyst

Stafford, TX

Full-time

Onsite

Senior Level

5+ years exp

Immatics is committed to making a meaningful impact on the lives of patients with cancer and is seeking a Senior Quality Control Analyst to join their Global Quality Operations team. The role involves performing bioanalytical, cell-based, and molecular assays to support product release and stability testing within the Quality Control laboratory.

Biotechnology

Comp. & Benefits

Hiring Manager

Jodie Q.

Responsibilities

Conduct Tests and Analyze Results: Perform routine and non-routine testing on products and materials to verify compliance with established standards

Collaboration: Manage, in collaboration with other team members, purchasing, receiving, formulating, testing, release of materials and reagents, equipment and assay qualifications and validation

Quality Records: Lead quality documents and processes such as GxP deviations, lab investigations, OOS/OOE, CAPAs, change controls, etc

Documentation: Author and conduct periodic review of procedures

Conduct and document all activities consistent with cGMP/GxP, regulatory filings, and written procedures

Maintain data integrity and logs for equipment

Data Analysis: Ability to analyze complex data sets and interpret results accurately. Able to identity trend and deviations, and take initiative to troubleshoot issues

Manage Laboratory Equipment: Perform and oversee the maintenance and calibration of laboratory equipment

Ensure Compliance: Involved in the creation of systems used in quality control to maintain compliance with regulations

Safety: Always demonstrate good safety practices and promote safety awareness

Train and support junior analysts

Transport controlled documents, QA-released QC materials and human biological samples

Assist with group tasks scheduling

Maintain knowledge of internal procedures and current regulatory requirements

Qualification

Bioanalytical assaysCell-based assaysMolecular assaysMethod transferAssay qualificationData analysisAseptic techniqueFlow cytometryCGMP knowledgeLIMS experienceStatistical softwareTechnical writingProblem solvingAttention to detailInterpersonal skills

Required

BA or BS in any science-related field

Minimum five (5) years experience in a regulated laboratory environment

MS degree or specialized skill set may substitute for 3 years

Experience as a QC personnel in a related field

Experience in aseptic technique, cell culture and either flow cytometry or cell-based assays

Preferred

MS in Biology, Biological Sciences, Laboratory Science, Biochemistry, or Biomedical Science/Engineering

Minimum five (5) years experience in a regulated laboratory environment

Laboratory skills include a few of the following: visual inspection, flow cytometry, molecular and cell-based assays

Demonstrate technical competence and knowledge in method transfer and assay qualification/validation activities

Excellent technical writing and troubleshooting/investigational skills

Demonstrate knowledge of cGMP/ICH/EU regulations and requirements

Experience writing GxP deviations, lab investigations, OOS/OOE, CAPAs, change controls, etc

Experience with LIMS and statistical software is a plus

Benefits

Competitive rates for Health, Dental, and Vision Insurance

4 weeks of Paid Time off, granted up front each year and prorated for first and last year of employment.

Sick Time Off – 56 hours

12 Paid Holidays

100% Employer-Paid Life Insurance up to at 1x annual salary

100% Employer Paid Short- and Long-Term Disability Coverage

401(k) with Immediate Eligibility & company match…

You are eligible for 401(k) plan participation as of your first paycheck.

The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment.

Partially paid Parental Leave for eligible employees. (3 weeks)

Additional voluntary employee paid coverages including Accident, Hospital Indemnity, and Critical Illness Employee Paid Identity Theft Protection and Pet Insurance.