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Quality Control Supervisor, San Jose
3 months ago
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 Control Team.
This position reports to the Site Quality Manager. The Quality Control Supervisor evaluates, tracks, trends, and monitors the Quality Control activities in an outsourcing facility. The position is responsible for the assurance that the drug product has the safety, identity, strength, quality, and purity represented. The candidate should have an excellent understanding of cGMP requirements.
The position requires an individual who works independently and in a team environment, experienced in cGMP requirements, quality control, attention to detail, and excellent communication with other functional areas and sites. Moreover, the role is responsible for promoting our mission of improving patient outcomes with high quality outsourced pharmaceuticals.
When will you work?
- The hours for this position are Monday - Friday 8:00am - 5:00pm.
What you'll do:
- Approve or reject starting materials, packaging materials, labeling and intermediate, bulk and finished products in relation to their specifications
- Evaluate completed batch records and other relevant information to ensure procedures were followed, product tests performed appropriately, and acceptance criteria met
- Review sampling instructions, specifications, test methods, quality control procedures, and standard operating procedures for intended use
- Approve and monitor analyses carried out under contract through private labs. Ensure that the appropriate validations, including those of analytical procedures, and calibration of control equipment are carried out
- Ensure that the required initial and continuing training of personnel is carried out and adapted according to need
- Investigate non-conforming materials, complaints, analytical failures, and returns
- Create, revise, control and issue documents, such as SOPs, batch records and technical reviews .
- Identify trends in the industry and recommend improvements
- Work with and supervise a team to ensure that the systems involved in an outsourcing facility are in a state of control
- Other duties as assigned to ensure appropriate quality practices
Who you are:
- Knowledge and experience with the US FDA cGMPs, preferably in a commercial compounding outsource facility
- Knowledge of compounding techniques and controlled environments
- Knowledge of appropriate materials and conditions
- Experience in environmental monitoring, sterile gown qualification, HPLC and other analytical testing relevant for pharmaceutical products
- Able to identify potential adverse issues
- Excellent organization and documentation skills
- Detail oriented
- Computer skills, including Microsoft Word and Excel
- Able to lift up to 20 lbs and stand for up to two hours when required
What you've done:
- Obtained a bachelor's degree in a scientific/technical discipline
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
Wedgewood is the nation's largest and most trusted provider of compounded veterinary medications. Its recent merger with Blue Rabbit enables the company to provide veterinarians with next-generation software to streamline patient care and marks a significant evolution in services. Together Blue Rabbit and Wedgewood serve more than 70,000 veterinary professionals and one million animals annually.
Wedgewood 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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