Quality Control Analyst I
Takeda
7 hours ago
On-site
Brooklyn Park, MN
$24.76 - $38.87 USD yearly
Operations
Quality Control Analyst
Responsibilities:
- Execute routine in-process, drug substance, and stability test methods.
- Use lab instrumentation and computer systems (e.g., LIMS, SoftmaxPro, Charles River Endoscan, MODA, Empower) to collect/record data.
- Maintain lab operations: cleaning, ordering supplies, reagent prep, stocking, waste disposal.
- Conduct facility monitoring (Environmental Monitoring, Critical Utility Monitoring) and product testing; review/maintain lab materials/instruments.
- Complete testing (including special project/protocol testing) in a timely manner.
- Maintain data integrity and comply with SOPs, specifications, and cGMP.
- Support low-risk deviations, CAPAs, and change controls in the eQMS.
- Initiate/own laboratory investigations; occasionally support department problem-solving.
- Author minor SOP revisions; may work overtime or different shifts; complete mandatory training.
- Perform equipment maintenance/calibrations as required; collaborate with Quality and Manufacturing Operations; other duties as assigned.
Qualifications & Skills:
- BS or MS in Life Sciences with relevant lab coursework; 0–3 years relevant experience.
- Previous regulated environment experience preferred; lab instrumentation experience preferred.
- Knowledge of cGMP and basic chemical/biological/microbiological safety procedures preferred.
- Strong QC analytical skills (HPLC/UPLC, UV-Vis, pH, CE, Osmolality, TOC, appearance, micropipetting).
- QC bioassay skills preferred (ELISA, cell maintenance/assays, plate readers, gels, icIEF, aseptic technique, biosafety cabinets; micropipetting).
- Basic computer skills; effective communication; read/write/converse in English.
- Eagerness to learn/continuous improvement.
Compensation/Benefits (summary): $24.76–$38.87 hourly; may include medical/dental/vision, 401(k) match, disability/life insurance, tuition reimbursement, PTO/sick time, holidays, and other well-being benefits.
Work Conditions:
- Stationary/standing for extended periods; lift/move up to 30 lbs; cleanroom gowning/PPE; occasional step ladder use; on-call/off-shift and 0–5% travel may be required.
Responsibilities:
- Execute routine in-process, drug substance, and stability test methods.
- Use lab instrumentation and computer systems (e.g., LIMS, SoftmaxPro, Charles River Endoscan, MODA, Empower) to collect/record data.
- Maintain lab operations: cleaning, ordering supplies, reagent prep, stocking, waste disposal.
- Conduct facility monitoring (Environmental Monitoring, Critical Utility Monitoring) and product testing; review/maintain lab materials/instruments.
- Complete testing (including special project/protocol testing) in a timely manner.
- Maintain data integrity and comply with SOPs, specifications, and cGMP.
- Support low-risk deviations, CAPAs, and change controls in the eQMS.
- Initiate/own laboratory investigations; occasionally support department problem-solving.
- Author minor SOP revisions; may work overtime or different shifts; complete mandatory training.
- Perform equipment maintenance/calibrations as required; collaborate with Quality and Manufacturing Operations; other duties as assigned.
Qualifications & Skills:
- BS or MS in Life Sciences with relevant lab coursework; 0–3 years relevant experience.
- Previous regulated environment experience preferred; lab instrumentation experience preferred.
- Knowledge of cGMP and basic chemical/biological/microbiological safety procedures preferred.
- Strong QC analytical skills (HPLC/UPLC, UV-Vis, pH, CE, Osmolality, TOC, appearance, micropipetting).
- QC bioassay skills preferred (ELISA, cell maintenance/assays, plate readers, gels, icIEF, aseptic technique, biosafety cabinets; micropipetting).
- Basic computer skills; effective communication; read/write/converse in English.
- Eagerness to learn/continuous improvement.
Compensation/Benefits (summary): $24.76–$38.87 hourly; may include medical/dental/vision, 401(k) match, disability/life insurance, tuition reimbursement, PTO/sick time, holidays, and other well-being benefits.
Work Conditions:
- Stationary/standing for extended periods; lift/move up to 30 lbs; cleanroom gowning/PPE; occasional step ladder use; on-call/off-shift and 0–5% travel may be required.