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Supervisor, QC Stability
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Email Me Similar JobsEmail Me This JobThrive in the dynamic and challenging environment of a contract development and manufacturing organization. Driven to excel through self-leadership and thriving team engagement.If this describes you, then look no further than LSNE. We have the experience, expertise and a successful track record in completing development of life-changing pharmaceuticals and medical devices. Together with our clients, we work to bring about treatment of many forms of cancers, Diabetes, communicable diseases, and many other illnesses. Come make a difference. Your work will matter and your contributions will be significant in these endeavors.We offer a competitive compensation and benefits package and a very generous paid time off benefit. Join our team!JOB SUMMARYThis position will have primary responsibility for supporting all activities within the Quality Control (stability) Laboratory, related to the on-time completion of testing for QC stability samples as required per the applicable stability programs. Additional areas of responsibility include but are not limited to QC data review / trending, investigational support & audit support (inspection readiness).JOB DUTIES -
Supervise the daily activities for the QC analysts (stability), ensuring all activities are completed as required per the stability testing program.
Influence and motivate staff to consistently meet deadlines set forth on the daily operational scheduling / huddle visual management boards.
Work with cross-functional teams (production, quality assurance, regulatory, commercial, project management, etc.) to support product campaigns defining stability requirements.
Support laboratory investigations and deviations, identifying root causes and enacting effective CAPAs to improve overall laboratory performance (%RFT).
Provide support in resolving technical QC issues
Perform testing, data review, data analysis, etc.
Author(s) and Revise(s) technical documentation (e.g. Stability Reports, SOPs, policies, forms, etc.) as required.
Develop direct report team through goal setting, performance management with regular review (i.e. 1 on1 meetings).
Implement and applies cGMP concepts in association with department specific responsibilities.
Actively engage in continuous improvement for areas of responsibility, collaborating with other departments to identify and implement process efficiencies.
Identify and implement safety initiatives in the laboratory that maintain and improve the work environment.
Drive testing efficiencies in order to reduced testing time and costs, improve compliance, and reduce safety risks. Ensures the QC laboratory operates in a state of audit readiness
Conflict resolution, problem solving in a cross functional setting, and ability to meet testing timelines.
Supports audits, including laboratory walkthroughs with client and regulatory agencies.
Other duties, as needed
PROFESSIONAL SKILLS -
Must have strong attention to detail as well as ability to work in a cross-functional team environment
Excellent organizational skills and the ability to work within a fast-paced environment
Must have proven logic and decision-making abilities, critical thinking skills.
Demonstrated leadership skills, able to engage motivate others
Multi-disciplinary knowledge of Quality Control
Strong capability for logical, analytical, and strategic thinking
Proficient in Microsoft Office, Excel, and PowerPoint.
Excellent communication and interpersonal skills are must.
Proficiency in standard QC laboratory equipment (HPLC, GC, FTIR, UV, KF, etc.) desirable
Background in data trending desirable
EXPERIENCE -
5+ years of relevant experience in a cGMP organization
3+ years stability program experience
Experience working in a cGMP/ laboratory required.
Experience working in a (CMO)contract manufacturing/development organization preferred.
Prior leadership experience is desired but not required.
Ability to work independently and in compliance with cGMPs
EDUCATION -Bachelor's degree in a scientific field with 5 or more years' experience in a CGMP / laboratory environment.QUALITIES -
Excellent interpersonal skills and the ability to communicate well both orally and in in writing
Ability to multi-task in a dynamic environment with changing priorities
Resilient, can quickly move forward despite challenges
A drive to achieve results for self, and the team, and is cable of working with limited supervision
Positive attitude and strong team, cross team collaboration
Honesty, integrity, respect and courtesy with leadership and peers
Strong commitment to conducting LSNE business according to the highest legal and ethical standards, and to continually pursue excellence in the manufacturing and delivery of LSNE products and services
PHYSICAL REQUIREMENTS & MENTAL DEMANDS -
Routine work requires walking, standing, bending, reaching, climbing stairs, lifting or carrying objects that typically weigh less than 50 lbs.
Capacity to work on several tasks simultaneously.
Able to organize and prioritize work activities.
Must be able to walk and drive between locations
Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves
Comfortable with working/handling of hazardous materials
COMMUNICATIONS & CONTACTS -
Works closely with the Quality Control organization in performing varied activities.
Interacts with all departmental staff to coordinate activities.
MANAGERIAL & SUPERVISORY RESPONSIBILITIES - NATRAVEL - <10%The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
