Sr Research Scientist - Stability Assessment
Company: Randstad Life Sciences
Location: Buena Park
Posted on: January 11, 2022
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!
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
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
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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