QC Validation Specialist Job at Covetrus, North America

Covetrus, North America Phoenix, AZ 85085

WHO WE ARE?

Covetrus is the global market leader in animal-health technology and services, dedicated to advancing the world of veterinary medicine and to empowering veterinary healthcare teams across the companion, equine, and large-animal health markets.

OUR VALUES

Never Settle – Share the Customer Goal – Give Power – Be Passionate – Do Good

Come join our amazing team where we go for great, put the customer first, operate as one team, cultivate a passion for animals, and always act responsibly for customers and society. Do you love animals? Then help us improve their lives daily!

JOB DESCRIPTION

This position will work under the supervision of the Quality Assurance Supervisor helping to perform all quality functions.

COMPANY BENEFITS

  • Medical, Dental, & Vision Insurance starting on Day 1
  • Generous holiday and paid time off policy
  • Company paid Life and AD&D insurance
  • 401(k) with generous company match
  • Pet Insurance
  • Employee Stock Purchase Program and more!

REQUIREMENTS

  • Experience with quality systems and document control
  • Understanding or familiarity with 21 CFR 210 and 211, 21 CFR 820, 21 CFR 11
  • Understanding or familiarity with ICH Q9, Q10, Q7
  • Understanding or familiarity with 503B Guidance for Industry for Outsourcing Facilities
  • Understanding of USP 795 and 797, cGMP, and pharmacy regulations preferred
  • 1-year previous experience with quality systems preferred
  • 3-5 years experience working in a laboratory or regulated environment preferred
  • Bachelors or Associates degree in any Science curriculum
  • A sufficient combination of education and work experience may be evaluated
  • Previous experience participating in regulatory audits is a plus

TRAINING REQUIREMENTS

  • General Company training requirements during orientation: Hazardous substance, Company policies, Human Resources Manual
  • Annual General Company training requirements
  • SOPs
  • Training in cGMP

COMPETENCIES (SKILLS AND ABILITIES)

  • Professional communication skills are a MUST
  • Attention to detail
  • Problem solving skills
  • Keeps calm in stressful situations and knows when to escalate issues to management
  • Collaborative Team Player who treats all personnel with Respect
  • Self-starter who can work independently
  • A PASSION for Patients and Quality
  • Familiar with Document Change Control procedures
  • Material control and qualification
  • Must possess a professional appearance
  • Strong verbal and written communication skills
  • Strong organizational and documentation skills
  • Ability to communicate in a respectful and professional manner with outside auditors, regulators, and inspectors

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

  • Keeps current on cGMP requirements for the 503B Outsourcing Facility
  • Schedule equipment cleaning, service, and maintenance
  • Knowledgeable regarding drafting and executing IQ/OQ/PQ validation protocols
  • Maintain a master list of all equipment
  • Perform temperature mapping on applicable equipment
  • Collaborate on SOPS/WKI/POL for use/cleaning/maintenance of all equipment
  • Perform routine audits on all equipment
  • Work cross-functionally with all departments including Pharmacists, Technicians, Management and QC laboratory personnel
  • Works on equipment investigations, out of specification events
  • Follows up on corrective actions and conducts effectiveness checks
  • A team member for external audits
  • Inspects incoming products which include non-sterile and sterile drug compounded finished product
  • Inspects products used in batch production
  • Retain sample inspection
  • Stays current on legal and regulatory environment for compounding
  • Identifying and solving problems
  • Assist with environmental monitoring throughout the facility

PHYSICAL DEMANDS/ WORK ENVIRONMENT

The physical demands and work environment are characteristic of those found in a typical laboratory environment. There is a potential exposure to chemicals used in the preparation of compounds and cleaning agents used in the facility. This position will require the ability to sit in an office or stand for an extended period. It also will require enough physical dexterity and fine motor skills to type, manipulate syringes, and work with delicate equipment and devices. The physical demands and work environment require enough flexibility and strength to undergo donning sterile garb from head to foot with all skin covered and ability to pass medical clearance to wear an OSHA 95 respiratory mask. Reasonable accommodations may be made for individuals with disabilities to perform essential functions. Must be able to read picking tickets and labels on products.

  • Manual dexterity
  • Adequate vision for tasks assigned

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.

Jobs that are in Colorado and other applicable area: If you are a Colorado applicant or applying for another applicable area, you are eligible to receive information about the salary range and benefits for this role. Please feel free to ask for further details when applying to the role.

Job Type: Full-time

Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Health insurance
  • Paid time off
  • Vision insurance

Schedule:

  • Day shift
  • Monday to Friday
  • Overtime
  • Weekend availability

Supplemental pay types:

  • Bonus pay

Ability to commute/relocate:

  • Phoenix, AZ 85085: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

  • What hourly rate are you looking for in a new position?

Work Location: One location




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