Quality Control Analyst II
Takeda
4 hours ago
On-site
Brooklyn Park, MN
$24.76 - $38.87 USD yearly
Operations
Quality Control Analyst II
About the Role
- Execute and review routine in-process, drug substance, and stability test methods in a timely manner.
- Use laboratory instrumentation and computer systems to collect and record data (e.g., LIMS, SoftmaxPro, Charles River Endoscan, MODA, Empower).
- Shift: Saturday to Tuesday.
How you will contribute
- Maintain lab operations (cleaning, ordering supplies, reagent preparation, stocking, waste disposal).
- Conduct test methods for facility monitoring (Environmental Monitoring, Critical Utilities), in-process, drug substance, and stability.
- Own and author quality system events (laboratory investigations, deviations, CAPA’s, change controls).
- Follow laboratory operations and Standard Operating Procedures (SOPs).
- Work in a lab environment for extended periods; review data; maintain materials and instruments.
- Complete testing, including special project/protocol testing, timely and appropriately.
- Maintain data integrity and comply with SOPs, specifications, and cGMP.
- Independently troubleshoot using generally defined QC procedures; moderate impact on future QC processes affecting batch disposition.
- Initiate/own investigations and moderate-scope, low-to-medium risk deviations/CAPA/change controls in the electronic QMS.
- Participate in cross-functional teams.
- Draft studies/investigations of moderate scope.
- Author new SOPs and update existing procedures.
- Train new QC Analysts.
- May work overtime or different shifts as needed.
- Perform equipment maintenance and calibrations; complete mandatory training.
- Perform other duties as assigned.
What you bring
- Bachelor’s or master’s degree in Life Sciences with relevant laboratory coursework.
- 3–6 years of relevant experience preferred.
- Previous regulated environment experience preferred.
- Must understand laboratory instrumentation.
- Effective communication with managers/peers; read/write/converse in English.
- Basic computer skills (word processing, spreadsheets, databases).
- Good interpersonal/team skills.
- Knowledge of cGMP manufacturing.
- Knowledge of chemical, biological, and/or microbiological safety procedures.
- Eagerness to learn and continuously improve.
Important Considerations (role conditions)
- Controlled clean/manufacturing environment with special gowning and protective clothing; may require hearing/respiratory protection.
- Work in cold, wet environment; may require multiple shifts/weekends and possible on-call/off-shift support.
- Travel up to 0–5%.
- Must be able to stand/sit for extended periods; lift/move materials/instruments up to 30 lbs; occasional ladder/stair climbing; dexterity/balance for cleanroom gowning.
Compensation and Benefits
- U.S. hourly wage range (Brooklyn Park, MN): $24.76–$38.87.
- May be eligible for short-term incentives; medical/dental/vision, 401(k) with match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, up to 80 hours sick time/year, and up to 120 hours paid vacation for new hires.
Application instructions
- Apply via the “Apply” button (acknowledgment required regarding application processing/Privacy Notice and Terms of Use).
About the Role
- Execute and review routine in-process, drug substance, and stability test methods in a timely manner.
- Use laboratory instrumentation and computer systems to collect and record data (e.g., LIMS, SoftmaxPro, Charles River Endoscan, MODA, Empower).
- Shift: Saturday to Tuesday.
How you will contribute
- Maintain lab operations (cleaning, ordering supplies, reagent preparation, stocking, waste disposal).
- Conduct test methods for facility monitoring (Environmental Monitoring, Critical Utilities), in-process, drug substance, and stability.
- Own and author quality system events (laboratory investigations, deviations, CAPA’s, change controls).
- Follow laboratory operations and Standard Operating Procedures (SOPs).
- Work in a lab environment for extended periods; review data; maintain materials and instruments.
- Complete testing, including special project/protocol testing, timely and appropriately.
- Maintain data integrity and comply with SOPs, specifications, and cGMP.
- Independently troubleshoot using generally defined QC procedures; moderate impact on future QC processes affecting batch disposition.
- Initiate/own investigations and moderate-scope, low-to-medium risk deviations/CAPA/change controls in the electronic QMS.
- Participate in cross-functional teams.
- Draft studies/investigations of moderate scope.
- Author new SOPs and update existing procedures.
- Train new QC Analysts.
- May work overtime or different shifts as needed.
- Perform equipment maintenance and calibrations; complete mandatory training.
- Perform other duties as assigned.
What you bring
- Bachelor’s or master’s degree in Life Sciences with relevant laboratory coursework.
- 3–6 years of relevant experience preferred.
- Previous regulated environment experience preferred.
- Must understand laboratory instrumentation.
- Effective communication with managers/peers; read/write/converse in English.
- Basic computer skills (word processing, spreadsheets, databases).
- Good interpersonal/team skills.
- Knowledge of cGMP manufacturing.
- Knowledge of chemical, biological, and/or microbiological safety procedures.
- Eagerness to learn and continuously improve.
Important Considerations (role conditions)
- Controlled clean/manufacturing environment with special gowning and protective clothing; may require hearing/respiratory protection.
- Work in cold, wet environment; may require multiple shifts/weekends and possible on-call/off-shift support.
- Travel up to 0–5%.
- Must be able to stand/sit for extended periods; lift/move materials/instruments up to 30 lbs; occasional ladder/stair climbing; dexterity/balance for cleanroom gowning.
Compensation and Benefits
- U.S. hourly wage range (Brooklyn Park, MN): $24.76–$38.87.
- May be eligible for short-term incentives; medical/dental/vision, 401(k) with match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, up to 80 hours sick time/year, and up to 120 hours paid vacation for new hires.
Application instructions
- Apply via the “Apply” button (acknowledgment required regarding application processing/Privacy Notice and Terms of Use).