Validation Chemist II

SUMMARY

Validation Chemist II's responsibility is to ensure method development and method validations are conducted for products of pharmacies and ensure validations follow regulatory requirements. Work under the method development and validation manager to develop and validate analytical methodologies, technically review validations and development work, generate validation reports, generate Standard Operating Procedures pertaining to method development and validation, implement training of new analytical methods, and effectively communicate issues to laboratory and quality assurance management.

If you are a passionate chemist looking to make a difference in animal healthcare and contribute to a leading veterinary pharmacy company, we encourage you to apply. Join Covetrus and help us improve the lives of animals and their owners through exceptional pharmacy services.

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

Validation Chemist II

• Responsible for developing and validating analytical methods for analyzing active pharmaceutical products for purity, potency, stability, impurities, etc.
• Performs test procedures including sub-visible particulate, dissolution, UV-Vis, FTIR, Container Closure, HPLC, etc.
• Documents work and maintains good laboratory records in notebooks and on controlled documentation according to Good Documentation Practices.
• Communicates results with the method development and validation manager and interacts closely with the quality assurance department to adhere to industry regulations.
• Troubleshoots and performs maintenance on laboratory equipment and analytical instrumentation.
• Assists with primary and secondary technical review as needed.
• Performs and leads with investigational testing for out of specification results and discrepancies during method validation.
• Informs method development and validation manager of any problems and/or deviations that may affect the integrity of the data and recommends corrective actions where appropriate.
• Provides input and participates in project meetings.
• Trains and assists quality control chemists and validation chemists on new methods and methodologies.
• Writes technical reports and standard operating procedures pertaining to method development and validation.
• Performs gap analysis on previously validated methods to ensure they follow continuously updated industry regulations.

SUPERVISORY RESPONSIBILITIES

• None

QUALIFICATIONS:

EDUCATION AND/OR EXPERIENCE

• Bachelor's degree in any Science curriculum. A sufficient combination of education and work experience may be considered.
• 3+ years' experience in a quality control laboratory.
• Preferred minimum of 6 months experience in method development or method validation
  • Understanding of 21 CFR 210 and 211, 21 CFR 820, and 21 CFR 11.
  • Understanding USP regulations.
  • Understanding of ICH Q2(R1).

CERTIFICATES, LICENSES, REGISTRATIONS

• None

COMPETENCIES (SKILLS AND ABILITIES)

• Attention to detail and strong organizational skills.
• Strong communication skills and ability to interact with parties internally and externally.
• Advanced decision-making skills.
• Computer Literacy with an intermediate understanding of Microsoft Office Suite including Word, Excel, PowerPoint, Outlook, and Teams.
• Ability to adapt to an environment with constant change.
• High integrity and willingness to adhere to and enforce regulatory guidance, policies, procedures, and regulations.
• Ability to comply with quality standards while working independently or in a team.
• Knowledge of study design and execution a plus.
• Self-motivated with superior time management skills.
• Must have the ability to work in a high paced environment and meet strict deadlines.
• Basic knowledge of scientific principles and concepts with strong mathematical and reasoning ability.
• Effectively communicates, verbally and in writing, and interprets and follows instructions.

PHYSICIAL 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 accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to lift at least 25 lbs. above the head.
• Ability to work long hours reading and writing, both paper and electronically.
• May work remotely up to 25% of scheduled week as business need allows.

About Covetrus: Covetrus is a leading global provider of animal health products, services, and technologies, dedicated to empowering veterinary professionals and improving animal health outcomes. We are committed to delivering innovative solutions that enable our customers to provide exceptional care to animals.

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.