QC Coordinator, Stability Operations
The QC Coordinator, Stability Operations is a member of the QC Stability Group. This position performs sample receipt and handling for stability study initiations (enrollment), timepoint pulls, thawing and aliquoting of drug substance samples, reconstitution of drug product samples and chamber monitoring. Activities performed utilizing software and other electronic systems such as Labware LIMS, EAMS, and QUN. Coordinate activities involving laboratory activities and schedules, serve as an SME within area of responsibility during on-site inspections and audits. In addition, non-lab support needed for investigations, corrective action/preventative action (CAPAs) and change controls. The person will also support creation and revisions of QC documentation such as SOPs. Prepares and reviews required documentation following good manufacturing practices (GMP). Utilizes related documentation systems. Will require participation in the on-call program rotation to support and respond to critical chambers alarms and to transfer material when necessary.
- Handles receipt of all Stability samples for enrollment into the QC Stability program and initiation of accelerated and special studies.
- Inspection of samples at receipt.
- Creates Monthly Thaw/Reconstitution Schedule.
- Submit Stability timepoints to the testing laboratories and perform drug substance thaws, aliquoting of samples, reconstitution studies, appearance assays when applicable.
- Utilize LabWare LIMS when applicable, for recording of Stability information related to stability thaw and reconstitution procedures.
- Reviews laboratory work for accuracy and compliance with procedures.
- Maintains QC Stability inventory and verifies calibration of laboratory and sample storage equipment.
- Assistance with data collection to fulfill the business needs during a QUN failure.
- Managing of laboratory reagents and materials.
- General cleaning and upkeep of laboratory.
- Ordering of laboratory supplies.
- Takes the initiative to drive process improvements to increase efficiency to work processes and ideas while actively sharing knowledge with others within the group.
- Must be able to use proactive thinking to anticipate potential challenges in projects and daily work resulting in a plan of action to mitigate risks.
- Must have the ability to prioritize responsibilities with respect to daily workload
- Support creation and revisions of QC documentation such as SOPs.
- Collaborates with other function areas to resolve issues related to stability sample storage.
- May represent work group within department teams
- Participate in on-call program rotation to support critical chambers.
- High school diploma or equivalent with 2 years of experience in GMP environment.
- Relevant Quality experience, preferably in the bio/pharmaceutical industry.
- Must have knowledge of GMPs and lab experience
- Proficiency with computer systems (Microsoft Office applications, MS Word, EXCEL).
- Strong interpersonal and communication (written and oral) skills and the ability to work well in a team environment are essential).
- Experience with LabWare LIMS, QTS Trackwise, PDOCS or similar document management systems.
- Experience with stability chamber performance and monitoring systems (QUN).
- Proficiency with LIMS desirable.
- Lifting trays/bins of samples in various container types (i.e. plastic bottles, stainless steel etc).
- Frequent walking, bending, sitting and standing requirements to facilitate support of staff on the floor (Laboratory).
- Ability to perform mathematical calculations.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Position is first shift Monday through Friday. Some off- hour support may be required to support priorities. Participate in on-call rotation to respond to equipment alarms 24/7 and to transfer material when necessary.
Other Job Details:
- Last day to apply: 05 AUGUST 2021
- Eligible for Relocation Assistance: NO
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