Job Description
SUMMARY
Covetrus is an innovative technology leader that helps veterinarians grow their practices and engage with their pet owners every day.
As a key member of our North America Quality & Regulatory team supporting distribution, theQuality Assurance Analyst I - DSCSA is responsible for supporting activities required to maintain serialization and track and trace information required for distribution of human and veterinary pharmaceuticals. This position will serve as a point of contact for product serialization, serial number management processes, track and trace regulations, and become knowledgeable regarding DSCSA (Serialization, Electronic notification of shipments) laws and Industry standards. This position will support sustainable processes, by working closely with key operations personnel and vendor partners to achieve business & customer quality goals. Experience in The Drug Supply Chain Security Act (DSCSA) or a regulated distribution business is preferred.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Supports the development, implementation, and ongoing management of Drug Supply Chain Security Act (DSCSA) requirements, as assigned
Executes plans for product level traceability.
Reviews and manages suspect and illegitimate product investigations and works with internal and external partners to resolve issues.
Develops a thorough understanding of the pharmaceutical supply chain including products and operations of wholesale distributors.
Develops technical competency working with various data sources and software programs supporting supply chain data, including ERP systems and product serial data systems.
Supports the generation, revision & implementation of In-Clinic Standard Operating Procedures (SOPs) ensuring the distribution (In-Clinic) business operates in accordance with applicable standards including any regulatory & accrediting body requirements.
As assigned, interacts with and maintains strong partnerships with external suppliers of serialization services as well as internal stakeholders including Operations, Procurement, Information Technology, Supplier Relations and Regulatory Compliance.
Serves as a backup point of contact for FDA, State Board of Pharmacies, NABP and/or other regulatory agencies on serialization data requests. Effectively manages and provides applicable documentation for requests and track/trend requests within the Covetrus electronic Quality Management System (eQMS) software application.
Serves as backup for authenticating and approving pedigree (track and trace) orders
Serves as backup for EPCIS file errors escalation and investigation
Identifies and raises quality issues and drives them to resolution. Monitors performance over time with a focus on improving product quality & overall customer experience. Communicates identified complaints per established process.
Performs additional duties as assigned and may cross-train to support other quality and regulatory activities.
QUALIFICATIONS:
EDUCATION AND/OR EXPERIENCE
Associate's Degree (required) Bachelor's Degree (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
COMPETENCIES (SKILLS AND ABILITIES)
Strong technical writing skills
Knowledge of the Drug Supply Chain Security Act requirements
Ethical conduct. Serves as a role model
Strong communication, collaboration, and team-building skills; ability to connect with all levels of the organization. Ability to influence both internal and external stakeholders.
Strong project management skills.
Creative thinker who can take on & problems and drive to resolution
Proficient Microsoft Office Excel, Word, and PowerPoint
Proficient knowledge of distribution center operations
Fundamental understanding of supply chain/supplier quality
Ability to take direction, provide instruction, and recognize the importance of and timing for reaching out to others to ensure high quality work output/performance
Ability to demonstrate initiative, possession of strong organizational skills and attention to detail
Ability to multitask and meet tight timelines established by federal and state agency reporting requirements and/or project timelines.
Ability to influence without authority to drive site wide compliance & quality execution
Strong communication skills as well as an ability to interact with all levels of the organization
TRAVEL
Strong Ability to Travel approximately 5% of the time
PHYSICAL DEMANDS/WORK ENVIRONMENT
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.
Pet-friendly environment
Extensive computer work
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all responsibilities, duties, knowledge, skills, and abilities required of individuals so classified. Reasonable accommodation may be made to enable individuals with disabilities to perform their duties and responsibilities. Covetrus reserves the right to change job descriptions as business need dictates.
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
* Sales Positions are eligible for a Variable Incentive
* Certain positions may include eligibility for a short term incentive plan
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.
Henry Schein Animal Health is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, and/or disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.
