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ACL Digital
Quality Control
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Job Description
Quality Control at ACL Digital Quality Control at ACL Digital in Ijamsville, Maryland Posted in about 21 hours ago.
Type:
full-time Onsite - Shift flexibility preferred
- Sunday-Wednesday
Time:
Day or Swing shift pending
IMPORTANT
For the first 7 weeks of the assignment, all contractors are required to work Mon-Fri (0730-1600) to complete New Hire Orientation and Manufacturing On-boarding Technical Training. After the 7 weeks, the contractor is deployed onto their agreed upon shift. New hires will need to complete Responsibilities (include but are not limited to):
- Perform testing of raw materials, intermediates and final products by following analytical methods: Cell based bioassays, Flow Cytometry, ELISA and qPCR assays.
- Work with internal and external resources to maintain lab in an optimal state.
- Assist with monitoring and trending data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Supply information to support generation of CoAs for product release.
- Maintains laboratory instruments for calibration and routine maintenance
- Author or revise SOPs, qualification/validation protocols and reports.
- Asist with lab investigations regarding out of specifications (OOS) results. Participate in determination of root cause for deviations related to analytical procedures.
- Provide updates at daily and weekly meetings.
- Monitor the GMP systems currently in place to ensure compliance with documented policies. Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
- Gather metric information for use in continuous improvement of areas of responsibility.
- Perform other duties as required.