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Job Details
Level
Experienced
Job Location
San Jose - San Jose, CA
Position Type
Full Time
Education Level
4 Year Degree
Job Shift
Day
Description
Great Care, Delivered™ is the promise that we make to our customers. If you have a passion for helping animals, and a love for serving others - we want you to help us deliver on that promise by joining our Team.
The Product Development Specialist contributes technical expertise to support efforts in product development, including drug formulation and analytical chemistry. This position provides clinical and technical services to the Quality department and ensures that all responsibilities will be performed in accordance with all relevant state and federal regulations.
When will you work?
The hours for this position are Monday - Friday 8:00am-4:30pm.
What you'll do:
Work in collaboration with Operations to develop new formulations that meet the clinical needs of our customers.
Create and manage change controls for preparations.
Respond to and support change controls generated by the organization which may affect finished product stability.
Document detailed product information into systems for use in technical services, customer services, materials management, manufacturing, and marketing.
Design and oversee product stability studies and generate final reports.
Leads investigation into deviations and identification and implementation of corrective actions related to product development.
Evaluate, change, and test current formulas through annual product reviews, quality requests, or patient feedback.
Coordinates and assists with feasibility studies.
Monitors and reports study progress/status on a site level.
Act as a point of contact to both corporate and director level individuals regarding product stability projects.
Develop and draft new product stability protocols with minimal supervision.
Assist in drafting R&D protocols and summary reports as needed.
Oversee and ensure reports, submission documentation, and development summaries documenting the product development process are available for clients, partners, and health authorities (i.e. FDA)
Responsible for performing investigations related to OOS laboratory testing.
Responsible for executing research and test method development projects for established and new products.
Who you are:
Familiarity with regulatory guidelines, specifically 21 CFR 210 & 211, USP 795, 797 & 800, ICH Q1AR2 and Q1D and 503B Guidance
Highly skilled in performing chemistry analysis related to stability studies, needing little or no guidance, including tracking and trending of data
Detail-oriented and understands the importance of accuracy and responsiveness
Positive, professional attitude
An excellent oral & written communicator with whom teammates and customers love to work
What you've done:
Experience in formulation of pharmaceutical product
Designed and performed product characterization/optimization experiments to identify critical process parameters
A Bachelor's degree, or equivalent in the sciences or related discipline is required.
What's in it for you:
A comprehensive benefits package that includes health, dental, and flexible spending accounts
401(k) retirement plan with a generous company contribution to help you save for the future
Company Paid Life and disability insurance
Access to voluntary insurance options
A generous paid time off program that increases every year
Tuition reimbursement
Opportunity for growth - We believe in promoting from within and do so through our internal job posting program!
About Us
For over 40 years, Wedgewood Pharmacy has been trusted to deliver high-quality compounded medications, now reaching over 40,000 people and the animals they love. Our company has grown dramatically from our humble beginnings in 1980 because we never stop asking how we can improve patient care while serving our customers better, smarter, and faster.
To keep growing, we depend on people who thrive on pushing the envelope of innovation in everything we do while keeping a laser focus on patient care. We trust our employees to deliver unique medications to the hundreds of thousands of people and animals whose health is our only business.
Wedgewood Pharmacy is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. If you require an accommodation due to a special need or disability, please let your recruiter know what accommodations you will need.
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Product Development Specialist, San Jose jobs in San Jose, CA, United States
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