Validation Chemist

Covetrus

Validation Chemist

SUMMARY

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

VALIDATION CHEMIST - DUTIES AND RESPONSIBILITIES

The following tasks are performed; however, other duties may be assigned.

• Responsible for validating analytical methods for analyzing active pharmaceutical products for purity, potency, stability, impurities, etc.
• Assists in the development of 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.
• Performs activity factor calculations and certificates for the pharmacy.
• Documents work and maintains good laboratory records in notebooks and on controlled documentation according to Good Documentation Practices.
• Communicates results with the Laboratory Management 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 Laboratory Management 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 laboratory projects.
• Trains and assists quality control chemists and validation chemists on new methods and methodologies.

SKILLS AND QUALIFICATIONS

• 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.
• Strong knowledge of study design and execution a plus.
• Project management experience a plus.
• Self-motivated with superior time management skills.
• Must have the ability to work in a high paced environment and meet strict deadlines.
• Intermediate/advanced knowledge of scientific principles and concepts with strong mathematical and reasoning ability.
• Effectively communicates, verbally and in writing, and interprets and follows instructions.

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.