Quality Assurance Technician, San Jose
San Jose, CA, United States
Job Details
Job Location
San Jose - San Jose, CA
Position Type
Full Time
Education Level
High School
Job Category
Pharmaceutical
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 Quality Assurance Team.
This position reports to the Quality Assurance Supervisor. The role is responsible for performing quality activities in a sterile pharmaceutical manufacturing facility. The candidate should understand pharmaceutical cGMP requirements. The position requires an individual who works independently and in a team environment, with attention to detail, and maintains communication with other functional areas and sites.
When will you work?
The hours for this position are Monday - Friday 8:00am-4:30pm.
What you'll do:
Release all components, drug product containers, closures, packaging, labeling, in-process materials, and finished products.
Monitor storage conditions of the manufacturing environment, materials, and products.
Maintain document control through review, approval and issuance of SOPs, batch records, labels and other controlled documents.
Review and retain all records associated with batch issuance, work instructions, release of product and all quality management data
Review laboratory data of the finished drug product, environmental monitoring, microbiological testing, chemical testing, in-process testing and stability testing.
Identify adverse trends and recommend improvements.
Communicate with Production and Shipping/Receiving to ensure appropriate materials and supplies inventory are appropriately qualified, documented, and suitable for intended use in manufacturing.
Investigate, review and trend deviations, OOS results and customer complaints.
Support equipment calibration, equipment/utility/facility validation, and preventive maintenance.
Participate in reviews of process qualification and product quality.
Manual QMS, including document control of SOPs, batch records, controlled documents, training module, and all quality activities.
Who you are:
Excellent written, verbal communication and presentation skills (preferred)
Ability to adapt to changing priorities and circumstances
Ability to think and act independently while knowing when to include others in decisions
Ability to work in a dynamic, fast paced and timeline-driven environment with shifting priorities
Strong understanding of Microsoft Office and Excel software
Experience in investigating and writing customer complaints (preferred)
Strong problem solving and decision making skills
What you've done:
1+ years' experience in a quality position at a cGMP facility. Fundamental knowledge of cGMP regulations as well as quality management systems.
High School Diploma or equivalent.
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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