The QC Laboratory Coordinator will coordinate management of samples, reagents, consumables and storage chambers within QC Laboratory. Serves as focal point for QC shipping requests to internal and external customers. Monitor processes to identify opportunities for continuous improvement. Serve as the subject matter expert on specific areas responsibility and proactively provides education, technical knowledge and support to less experienced scientists.
**Shift Hours: Monday – Friday, normal business hours**
Your responsibilities will include, but are not limited to:
• Serves as department liaison for sample coordination and sample management
• Drives sample, receipt and shipping to internal and external customers
• Supports and drives internal samples receipt processes
• Ensures organization and accurate inventories are maintained for cold storage units including; 2-8ºC, -20ºC, -80ºC and LN2
• Ensures critical reagent supply is available within laboratory at all times including but not limited to; Microorganisms, cell banks, qPCR samples and Flow cytometry assays.
• Responsible for management of terminated lot closeout within department
• Ensures timely archiving of documentation associated with area of responsibility
• Train other associates in specific areas of competency.
• Ensures cleanliness of laboratory working areas
• Draft presentations as required
• Contribute and supports writing of OOS/OOE/OOT and deviation investigations.
• Drives designing and executing CAPA outcomes
• Revises and/or creates SOPs and forms as required using appropriate electronic systems.
• Follows GxP quality policies and procedures.
• Drives 5S and Lean projects.
• Takes on non-standard duties (i.e. HS&E representative)
• Ensures all assigned training is completed within required time-frame.
• Performs testing in support of release strategies when required
• Perform daily equipment startup, shutdown and equipment calibration/PQ (when re-quired)
• Assists and supervises equipment and metrology teams in troubleshooting equipment is-sues
• Supports external teams in qualifying new and/or replacement equipment within the laboratory
• Work on shifts covering daytime / evening and one or both weekend days.
• Performs other job duties as assigned.What you’ll bring to the role:
• BA or MS in Cell biology Immunology, Molecular biology, virology, biochemistry, microbiology or other related science.
• 5 years of experience in the pharmaceutical/Biotechnology industries conducting QC testing, release testing and coordinating the activities of a QC laboratory.
• Thorough knowledge of cGxP expectations
• Knowledge of ICH, Eur. Ph., USP and FDA and JP guidelines.
• SME level knowledge of a particular area of QC laboratories
• Experience using LIMS systems
• Experience in supporting internal and/or external laboratory audits
• Advanced written and verbal communication skills
• Advanced experience in the use of computer based systems and applications associated with bioanalytical testing
The pay range for this position at commencement of employment is expected to be between $88,000 and $132,200/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Why Novartis?
236 million lives were touched by Novartis medicines in 2022, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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