About the company
A career at the company offers opportunity, ownership and impact.
All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Quality Support Services is looking for a highly motivated Senior coordinator to support the Stability operations program requiring study initiation, thaws, drug substance aliquot, DP reconstitution studies, appearance assays and timepoint pulls. The candidate will also support bringing in new products into the stability lab as well as maintaining the stability equipment. This position supports the Central File Room by filing and archiving documents and data packs and managing and creating QC logbooks. This position may include cross training to. support manufacturing and the QC testing laboratories by managing sample pickup, delivery and sample chain of custody.
Performs all work in compliance with cGMPs, site and regulatory requirements
Performs receipt, study initiation, time point pulls for stability material
Performs appearance assays when applicable
Is able to perform DP inspections
Strong communication skills and the ability to resolve issues in a timely manner working with related groups
Perform laboratory functions, housekeeping and maintain a safe and compliant work area.
Experience working in a GMP environment
Familiar with Laboratory information Management systems
Good attention to detail
Ability to work and complete assignments independently
Proactive in taking the initiative to problem solve and identifying continuous improvement opportunities
The position requires the ability to problem solve with related groups
75-90% of the time walking
Ability to lift between 15 and 40 lbs
Must be able to work with needles and work aseptically
Must be able to pass requirements for close inspection work.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Required to be able to work at 7am - 3:30pm Occasional changes to shift ( 8:30 am - 5:00pm)
Occasional overtime may be required
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
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