Quality Assurance Specialist - Investigations
Job 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 Team.
As Quality Assurance Specialist - Investigations you will assist with quality assurance responsibilities within our lab operations. We are a compounding pharmacy operating in a multi-site environment. The responsibilities of the Quality Assurance Specialist include customer complaints, product quality investigations, supplier qualification, internal audits, change controls, and risk assessments. You will assist with Continuous Improvement plans and maintain and review all Corrective Actions/Preventative Actions (CAPAs), and Effectiveness checks. You will collaborate with the operations team and quality team across the organization. You will also assist with the implementation of a quality management system.
When will you work?
- The hours for this position are Monday – Friday 8:30 am – 5:00 pm, this is an onsite position in our Swedesboro, NJ office.
What you’ll do:
- Support investigations, including customer complaints, by trending investigations, assessing the criticality of the issue, assigning to the appropriate investigator, and reviewing/approving all investigations/CAPAs/effectiveness checks.
- Confirm that all NJ customer complaints are documented correctly and accurately and assigned to the appropriate department for review/investigation.
- Manage the NJ Internal Audit Program by performing internal audits of the Warehouse/Dispensing Operations, Internal Laboratory Operations, and Pharmacist Quality functions to verify compliance with all applicable regulatory authority requirements and issue the observations in a timely manner.
- Review and approve change controls.
- Perform and review risk assessments.
- Support the External Vendor Audit Program as directed by Quality Management.
- Participate in cross-functional teams in preparation for regulatory inspections, quality agreements, internal and external auditing, validation activities, and special projects.
- Work collaboratively with Operations and Pharmacist personnel.
- Supports quality system creation/implementation as assigned by Quality Management
- Provides Quality Event metrics/trends to Quality Management.
- Stays current with applicable pharmacy regulations and internal quality standards.
- Perform tasks in accordance with applicable regulations, Company quality standards, policies, and procedures.
- Other duties as assigned by Quality Management.
Who you are:
- You bring a positive, professional attitude
- Have strong organizational skills
- Ability to work independently and in a team environment
- Thrive in a fast-paced environment and adapt to changing priorities
- Detail-oriented individual who understands the importance of accuracy and responsiveness
- Ability to collaborate with team members and cross-functionally
- Excellent communicator, both written and verbal, and strong decision-making skills
- Ability to proficiently use Microsoft Office
What you’ve done:
- Bachelor’s degree in scientific/technical discipline
- Experience working in a regulated environment or equivalent experience required
- A minimum of 3-5 years of investigation experience heavily utilizing various root cause analysis methodology
- Six Sigma or RCA certification
- Must be registered or capable of becoming registered with the state of New Jersey as a pharmacy technician
- Obtained a working knowledge of USP monograph testing as well as the USP monographs/sections that pertain to pharmacy compounding (a plus!)
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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