Regulatory Quality Assurance Analyst

Covetrus • Full-time • Ohio (US) 1 - Remote 100%, United States of America • 2d ago

TheQuality Assurance Analystroleexecutes Quality Assurance related tasks for In-Clinic & PharmacyQuality Assurance (QA). This role works closely with and under the leadership of the Quality Assurance Supervisor toEnsure thatprocedural and operationalpractices are executed consistently and effectively, meeting allregulatory requirements while supporting businessneedsthrough proactive, efficient, standardized qualityprocesses.

Responsibilities

Quality Operations & Execution

Execute day-to-day Quality Assurance activities to ensure products, suppliers, and processescomply withregulatory requirements and internal quality standards.

Manageand supportcomplaint handling activities, including intake, investigation, documentation, corrective actions, and closure.

Support Nonconformance Event (NCE) and CAPA processes, including initiation, investigation support, follow-up, and documentation.

Consistently execute quality activities related to:

Recall support and documentation

Supplier approval and ongoing monitoring

Drug Supply Chain Security Act (DSCSA) compliance

In-Clinicnew itemaddapprovals

Compliance & Documentation

Adhere to SOPs, work instructions, regulatory requirements, and quality standards.

Ensureaccurate,timely, and compliant documentation within the Quality Management System (QMS).

Identify, document, and escalate quality risks, deviations, and trends asappropriate.

Collaboration & Continuous Improvement

Support internal audits, regulatory inspections, and quality assessments.

Identify process inefficiencies, quality issues, and potential risks; communicate findings to the Quality Assurance Supervisor and support improvement initiatives.

Collaborate with QA leadership and cross-functional partners to investigate and resolve quality issues.

Complete all required trainingin accordance withestablished timelines.

Perform other duties as assigned to support quality and businessobjectives.

Required Knowledge and Skills

Strong technical writing skills with the ability to produce clear,accurate, and compliant documentation.

Working knowledge of Drug Supply Chain Security Act (DSCSA).

Demonstrated ethicalconduct;serves as a role model for quality and compliance.

Strong verbal and written communication skills, with the ability to collaborate effectively across all levels of the organization.

Strong organizational skills, attention to detail, and the ability to manage multiple priorities and meet tight timelines.

Demonstrated initiative and problem-solving skills with the ability to drive issues to resolution.

Proficiencyin Microsoft Office applications (Excel, Word, PowerPoint).

Ability to take direction, provide input, and recognize when to escalate or seek collaboration to ensure high-quality outcomes.

Education

Associate degree or equivalent experience, such as certification and professional practice as a Veterinary Technician or Pharmacy Technician (required)bachelor’sdegree (preferred) in a related field: Chemistry, Biology, Health Administration, Animal Health, Business, Nursing, Pharmacy, Microbiology, Supply Chain

Minimum of 1-3 years of related experience with exposure to quality, supply chain management (distribution) and/or pharmaceuticals or combination of equivalent education and experience.

Certificates, Licenses, Registrations

Certified Quality Professional (CQE, CQA, etc.) a plus

Lean Six Sigma (or other Continuous Improvement) certification a plus

Covetrusis an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. 

We offer the following benefits for you to take advantage of while you are here provided you meet the eligibility requirements under each governing program:

401k savings & company match
Paid time off
Paid holidays
Maternity leave
Parental leave
Military leave
Other leaves of absence
Health, dental, and vision benefits
Health savings accounts
Flexible spending accounts
Life & disability benefits
Identity theft protection
Pet insurance
Certain positions may include eligibility for a short-term incentive plan

Salary may vary depending on factors such as confirmed job-related skills, experience, and location. It is not typical for an individual to be hired at or near the top end of the range for their role. Compensation decisions are dependent upon the facts and circumstances of each case. Sales Positions are eligible for a Variable Incentive.

The pay range for this position is as follows:

$46,400-$61,800

Covetrus is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.