This listing was posted on The Resumator.
Supervisor, QA OTF Support
Location:
Baltimore, MD
Description:
This position may follow a 7AM-7PM 2-2-3 rotating schedule and is 100% on site at the Baltimore, MD facility.Our client is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and employee. The Role: Provide oversight of the “QA on the Floor” program and supervision of OFT 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. Drives and owns the “Quality on the Floor” program by facilitating the desired ‘way of working’ and a quality culture; plans and coordinates the activities of the OTF team to ensure coverage for all manufacturing activities. 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 etc; play a key role with resolution of quality investigations and CAPAs. Ensure that own and teams KPI’s, plans, targets and objectives are effectively monitored and achieved. Including standard lead-times and supporting the Business goals for e.g. RFT and OTD/ OTIF; embrace and actively drive Practical Process Improvements (PPI). 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. Leads by example, keeping in mind organizational values, policies and goals. Develops people and team coaching and collaboration; proactively partners with Human Resources to attract and retain top talent and takes an active role in ensuring new employee onboarding is a success. Other duties as assigned. The Candidate Requirements: 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 preferred; Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks. Creative individual with excellent analytical, trouble shooting, and decision-making skills; ability to quickly learn new and novel manufacturing processes supporting new clients; ability to produce results in a fast-paced environment to meet client deadlines; able to work in a team setting and independently, under supervision; creative thinking with the ability to multi-task; commitment to ongoing professional development. Powered by JazzHR
Company:
Medvacon Life Sciences
Posted:
October 10 on The Resumator
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More About this Listing: Supervisor, QA OTF Support
Supervisor, QA OTF Support is a Quality Assurance QA Job at Medvacon Life Sciences located in Baltimore MD. Find other listings like Supervisor, QA OTF Support by searching Oodle for Quality Assurance QA Jobs.
Supervisor, QA OTF Support is a Quality Assurance QA Job at Medvacon Life Sciences located in Baltimore MD. Find other listings like Supervisor, QA OTF Support by searching Oodle for Quality Assurance QA Jobs.