QC Sample Coordinator
Role = QC Sample Coordinator
Duration = One year from start date, with possible 6-month extension
Standard Day Shift (40 hrs/wk; 8 hrs/day)
Overtime or Weekends = May be necessary so candidates should be open to it.
100% Onsite (even throughout COVID)
This role will support all groups within the QC department through managing samples, material, and documentation flow. Includes sample and material reception, allocation, and sample shipments to OTLs. Prepare, distribute and files controlled documents for department.
• Receive, prepare and distribute all incoming sample products, EM/utility samples, bulk materials, in process materials, and components. Communicate receipt of labs, in accordance with criticality of test initiation times.
• Receive, de-label, and manage sample retention storage.
• Manage shipment of QC samples to OTLs. Prepare necessary shipping documents, and coordinate shipments to ensure a timely shipment. For Wavre shipments, track samples through shipping process and communicate delays in receipt.
• Follow and work in accordance with company policies, SOPs and cGMP standards to ensure compliance with all applicable regulations.
• Perform additional tasks throughout QC to help support the team, i.e. utility sampling.
• Lead investigator for unplanned events.
• Write, revise and assist with SOPs for department.
• Work independently. When assigned to rotating shift work; work independently and without direct supervision to perform normal operating routines and emergency response procedures.
• Perform all tasks with a safety mindset. Following the EHS guidelines established on site.
• Manage all aspects of sample flow into and out of QC department according to departmental SOPs.
• Serve as the lead staff member responsible for sample and document management.
• Follow established procedures and policies to maintain sample and document cGMP compliance.
• Communicate with QC technicians sample availability/readiness for testing.
• Communicate with other site groups to coordinate efficient, effective, and compliant sample pickup and drop-offs.
• Continuously provide feedback and offer suggestions improve quality and efficiency of operations.
• High School diploma or equivalent and 1 or more years of experience in administrative support, or similar role whose responsibilities included material and sample flow, documentation, and\or inventory management. Associates Degree including completion of relevant science courses preferred.
Other Job-Related Skills/Background:
• Intermediate computer skills in MS Excel and MS Word, the ability to work with data within documents.
• The ability to communicate effectively both verbally and in writing with all levels, both inside and outside of the organization. The ability to clearly write and communicate sample and document movements.
• Prefer GMP and SOP work environment experience.
• Ability to follow written procedures and document actions in a neat and precise manner according to GMP requirements.
• The ability to interact with peers and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QA.
• Able to prioritize and decide appropriate course of actions.
• Proven record of providing excellent internal and external customer service.
• Must have demonstrated self-direct work habits and strong communication skills.
• Stay current on developments in the field and company standards.
• Demonstrated familiarity with cGMP's, facility regulatory guidelines and standard operating procedures.
• The capability to maintain attention to detail and quality and a high level of integrity and confidentiality, while completing multiple or repetitive tasks and meeting timelines and deadlines.
• This is a 24/7 operation, this individual may need to provide coverage 24/7 to include holidays, and weekends; over-time may be required.
• Must be a committed team player prepared to work in and embrace a team based culture
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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