Location: San Jose, CA
Company: Wedgewood Pharmacy
you to help us deliver on that promise by joining our Quality Team. The role is responsible for evaluating and validating the equipment and procedures used in development and production of a variety of products. Additionally, this role ensures all systems are running according to necessary specifications and operates within regulations to ensure the production of quality products for the Company's 503B c GMP manufacturing facility.
When will you work? The hours for this position are Monday - Friday 8:00am - 4:30 pm. What you'll do: Schedule, plan, manage and execute studies for cleaning verification and validation. Review and approve validation project documentation. Coordinate and interface
with the process unit heads, quality and engineering groups for assuring successful project execution. Lead and coordinate cross-functional teams for project validation.
Prioritize, manage, and execute multiple projects utilizing the project management methodologies. Support the development of best and proven validation practices in the validation department, based upon current industry guidelines and practices. Author relevant standard operating procedures for ensuring compliance with the company's policies. Support regulatory submissions and regulatory agency inspections whenever required. Supervise external resources for completion of critical tasks. Who you are: Ability to take ownership
and accountability for the Validation function across multiple fast paced projects.
Computer System Validation (CSV) experience with process control and automation systems Experience with automation, commissioning, qualification or operations in a c GMP environment. Direct experience developing validation protocols and execution of protocols. Knowledge of current industry standards such as GAMP5 and ASTM E2500. Tactical thinker with experience working with customers developing testing, validation and/or quality strategies. Excellent client communication skills. What you've done: Obtained a bachelor's degree in life sciences or engineering At least 5 years of experience in a highly regulated environment like biotechnology, medical or related fields, including a significant exposure to regulatory requirements.
Experience in project management. Knowledge of c GMP requirements as they pertain to the validation of manufacturing and lab equipment in a medical environment. 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 shop 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 shop 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. PDN-9ae7eb45-9d93-4fd7-b914-b008c74c9741
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