Title: Quality Assurance Specialist
Contract Duration: 3 months
Location: Columbia, Maryland, United States
Shift Timing/ Schedule: (Day Shift: 7am-7pm EST OR Night Shift: 7pm-7am EST) Work 2,2,3 Schedule (Alternate Weeks)
Job Description:
- Provide oversight of the QA floor program and supervision of processes and personnel.
- Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines; build effective teams that apply their diverse skills and perspectives to achieve common goals; oversee daily activity for the group to ensure quality results Performance management for direct reports.
- Provide QA oversight, technical expertise and leadership across all aspects of product manufacturing and operations support; develop and update relevant procedures; monitor, participate and oversee the real time batch record review process, including escalation of issues while on the floor.
- Ensure manufacturing compliance with applicable procedures and batch records; review manufacturing shop floor documentation, including logbooks, calibrations, play a key role with resolution of quality investigations and CAPAs.
- Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
- Partner with manufacturing and key stakeholders to prioritize projects aligning with the quality goals and objectives; ensure quality events are captured, investigated and closed appropriately in the Trackwise system.
- Actively participates in training activities, managing their individual training plan; also ensures interaction with other shifts given the 24/7 operations.
Qualifications:
- Masters’ degree in a Scientific, Engineering or Biotech field with 4+ years’ experience in Quality Assurance/ Quality Control/ Manufacturing within biologics, biopharmaceuticals, or a regulated industry OR Bachelor’s degree in a Scientific, Engineering or Biotech field with 6years’ experience in Quality Assurance/Quality Control/ Manufacturing within biologics, biopharmaceuticals, or a regulated industry.
- Familiarity with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs; Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish.
- Familiarity with electronic systems, including developing and producing reports using Microsoft products. LIMS, Master Control and Trackwise knowledge.
