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Quality Control Supervisor, San Jose
3 months ago
- San Jose, CAPosition TypeFull TimeEducation Level4 Year DegreeJob CategoryPharmaceuticalDescriptionGreat Care, DeliveredTM is the promise that we make to our customers.
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 specificationsEvaluate completed batch records and other relevant information to ensure procedures were followed, product tests performed appropriately, and acceptance criteria metReview sampling instructions, specifications, test methods, quality control procedures, and standard operating procedures for intended useApprove 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 outEnsure that the required initial and continuing training of personnel is carried out and adapted according to needInvestigate non-conforming materials, complaints, analytical failures, and returnsCreate, revise, control and issue documents, such as SOPs, batch records and technical reviews .
Identify trends in the industry and recommend improvementsWork with and supervise a team to ensure that the systems involved in an outsourcing facility are in a state of controlOther duties as assigned to ensure appropriate quality practicesWho you are:Knowledge and experience with the US FDA cGMPs, preferably in a commercial compounding outsource facilityKnowledge of compounding techniques and controlled environmentsKnowledge of appropriate materials and conditionsExperience in environmental monitoring, sterile gown qualification, HPLC and other analytical testing relevant for pharmaceutical productsAble to identify potential adverse issuesExcellent organization and documentation skillsDetail orientedComputer skills, including Microsoft Word and ExcelAble to lift up to 20 lbs and stand for up to two hours when requiredWhat you've done:Obtained a bachelor's degree in a scientific/technical disciplineWhat'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.
If you require an accommodation due to a special need or disability, please let your recruiter know what accommodations you will need.
