- King of Prussia, PA
Site Name: USA - Pennsylvania - King of Prussia
Posted Date: Mar 13 2020
Are you interested in working with cutting-edge laboratory technology to improve quality and accelerate regulatory compliance? If so, this Biochemistry Supervisor role could be an exciting opportunity to explore.
As a Biochemistry Supervisor, you will provide first line supervision to QC analysts, who are responsible for utility, in-process, and BDS testing and also serves as a leader outside of their immediate role in regards to testing and system optimization, driving continuous improvement, and participating in cross functional and cross business collaboration and teamwork.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
- Schedules and assures adherence to schedule for the performance of utility, bulk, validation and finished product testing for biochemical analysis, so that all testing to support the production and release of product lots is performed in compliance to internal procedures and standards and external regulatory standards.
- Reviews and approves biochemistry test results for in-process, bulks, finished products, and validation testing.
- Reviews and approves investigations, change controls, protocols, validation reports.
- Writes, updates, reviews, and approves Laboratory Standard Operating Procedures, Analytical Methods and Specifications and troubleshoots laboratory test problems.
- Evaluates new equipment for purchase.
- Assesses new technologies for application to site operations
- Performs administrative duties, i.e. hiring, discipline and performance evaluations.
- Assures that laboratory equipment is calibrated and in good working condition, purchases supplies and equipment.
- Utilizes GPS tools and processes to continuously improve efficiencies and ensured adherence to schedule.
- Responsible for ensuring laboratories are operated in a state of control with regards to current LSOP's, GMP's and regulations and Biochemistry SME for internal and external regulatory audits and inspections.
Why you? Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in a science discipline
- 5 years in a GxP regulated laboratory environment
- 2 or more years of experience supervising a team
If you have the following characteristics, it would be a plus:
- Demonstrated supervisory and leadership skills
- Strong interpersonal and leadership skills. Solid team player able to function within team based organisation.
- Strong verbal and written communication skills.
- Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QA.
- Able to prioritise and decide appropriate course of actions. Effective at implementing decisions
- Fully versed in GMP's, NIH, ICH Guidelines, FDA and other regulatory agency requirements for validation and operations of analytical and stability functions.
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
*This is a job description to aide in the job posting, but does not include all job evaluation details.
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