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Sr Research Scientist - Stability Assessment

Company: Randstad Life Sciences
Location: Buena Park
Posted on: January 11, 2022

Job Description:

The world's leading global brand in vitamins, minerals and dietary supplements located in Southern California is seeking a Sr Research Scientist - Stability Specialist. This Stability Specialist will sit on a cross functional research and development team whose work will be focused on ensuring all Nutrition products meet shelf life and label claim requirements. This team's work remains focused on ensuring high nutrition product quality standards while supporting optimization efforts within the diverse supply chain. Your teamwork will continue to position the company as the leading direct selling company in the world by offering innovative product solutions that provide high value to customers and their communities. You will add energy and inspiration to a strong technical team!

Essential Duties and Responsibilities:
As a Stability Specialist on this key team, you will oversee and be accountable for design, review, implementation, and analysis of nutrition product stability studies.
You will develop strong partnerships with Quality Assurance, Regulatory Affairs, Manufacturing, Procurement, Planning and Product Development Scientist to deliver stability recommendations to support all product development projects including new products, re-registration of existing products, and relevant supply chain changes for products in the existing global portfolio.
Your role will be critical to ensuring preparedness for site inspection activities and external audits in partnership with QA, and as the leader of the stability program you will have the opportunity to pursue continuous improvement of the program and implement new ideas to improve working efficiencies.
If you are seeking an opportunity that offers program ownership, the chance to showcase your technical capabilities, and exposures on a global scale, this role can offer a strong platform to spotlight your talent!

Basic Qualifications:
BS in life science or equivalent with a minimum of 7 years analytical/quality control experience in a commercial/global cGMP quality assurance/quality control biotech or pharma setting with a focus on stability.
Working knowledge of relevant and current FDA, EU, ICH and other global guidelines and regulations.
Working knowledge of relevant global regulations and standards/guidelines and experience in participating in successful regulatory inspections / audits as related to stability.
Deep functional knowledge of the principles and applications of consumables product development & stability
Demonstrated proficiency with quality system records, deviations, change controls and CAPAs
Knowledge of clinical and commercial GMP QC stability
Working knowledge of statistical analysis programs and software, e.g, MINITAB, JMP, Looker, Statistica, Spotfire, etc. for performing trend analysis and reporting of stability data and metrics.
Experience with and working knowledge of electronic databases - StarLIMS, JD Edwards, PLM, OBIEE preferred.
Analytical Lab tools and techniques & safety principles.
Interacting with cross functional teams to achieve defined objectives through consulting and positive interaction with culturally diverse team members, external partners and clients.
Planning, organizing, monitoring and controlling projects; ensuring efficient utilization of technical resources and appropriate mitigation of risk to achieve project objectives.

Preferred Knowledge, Skills and Abilities:
Identifying and anticipating problems, reviewing related information, developing and evaluating options, making decisions and implementing solutions.
Effectively communicating and presenting technical complex data (both verbally and written) to influence all levels and global audiences.
Processing, documenting and providing timely information with a high level of accuracy in a usable format.
Continuously seeking and sharing new developments, advancements and knowledge in relevant fields.
Successful approaches, tools, and techniques for dealing with changes and adapting to a changing environment; adapting as needed to meet the requirements of the business.
Use of related analytical and scientific instrumentation, software, databases and applications to include typical office suite software packages and demonstrated proficiency and expertise with MS Office programs (Outlook, PowerPoint, Excel, Word)

This role is NOT eligible for sponsorship

Keywords: Randstad Life Sciences, Buena Park , Sr Research Scientist - Stability Assessment, Other , Buena Park, California

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