- The hours for this position are Monday - Friday 8:00 am - 4:30 pm.
- Support QMS compliance with the appropriate internal and external regulatory requirements and maintain awareness of the overall regulatory landscape.
- Contribute to the development of optimum, future state of the QMS.
- Maintain the divisional Quality Manual, Quality Plans and Quality Policy, ensuring they are reflective of changes in business scope, QMS and regulatory requirements, and appropriately utilized throughout the division.
- Develop procedures and controls in support of the Quality Management System.
- Compile and report monthly metrics related to quality systems.
- Support in Quality Planning reviews and related forums.
- Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS.
- Oversee and execute developments and / or modifications to QMS.
- Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
- Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations and Facilitate uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
- Liaise and communicate with Quality assurance, Quality control, Validation department in regard to any changes or improvements in QMS or regular day to day duties.
- Dedicated achiever. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
- Goal-oriented developer. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
- Collaborative partner. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
- Team Player: Will align between the team's topmost goal and mission and team members' activities and conversations on the ground.
- Bachelor's degree in engineering or related discipline
- Minimum 2 years experience in the pharmaceutical industry or an equivalent regulated environment, with a focus on quality and regulatory systems.
- Knowledge of regulations, standards, and industry practices associated with QMS.
- Experience participating, supporting and/or organizing internal and external audits is preferred.
- Strong knowledge of quality systems (Quality Planning, Management Review, Internal Audit, CAPA, Document Controls, etc.)
- 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
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Quality Systems Specialist - San Jose, United States - Wedgewood
Description
Job DetailsLevel
Experienced
Job Location
San Jose - San Jose, CA
Position Type
Full Time
Education Level
4 Year Degree
Salary Range
$35.00 Hourly
Job Shift
Day
Job Category
QA - Quality Control
Description
Great Care, DeliveredTM 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 Team.
When will you work?
Responsible for performing daily quality functions including:
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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