Plymouth, MI, United States
SeniorFull Time
50 seconds agoView role
Assist with preparation for inspections by state boards, DEA, FDA, and accreditation boards (PCAB, NABP, etc)
Organizing and conducting internal quality system audits, playing an active role in external audits and regulatory inspections.
Assist in developing, reviewing, and maintaining Standard Operating Procedures (SOPs) for compounding, labeling, packaging, and dispensing.
Support adherence to USP <795>, <797> and <800>, VPP, and PCAB requirements where applicable to veterinary compounding.
Review and audit compounding logs, formulation worksheets, and beyond-use dating assignments for accuracy.
Develops, executes and analyzes QA reporting metrics, reports on quality issues and trends during monthly QMS meetings.
Qualification and validation procedures for equipment and processes.
Communicating with other team members to solve problems.
Following up with the appropriate channels when mistakes are found.
Performing other duties as requested, directed, or assigned.
Bachelor’s degree in pharmaceutical sciences, chemistry, biology, or related field preferred; Certified Pharmacy Technician (CPhT) a plus
You have at least 1-3 years of experience working with a registered quality system in pharmaceutical production and/or manufacturing environment, FDA Good Manufacturing Practices and regulatory audits preferred.
You have very strong Microsoft Office Suite skills (Word, Excel, Outlook, etc) and ability to learn and operate other specific applications software.
You have strong oral and written communication skills, including making presentations, delivering training, writing/reviewing documentation, and working with auditors
You have the ability to read and understand complex regulations and requirements and develop pragmatic compliance solutions
You are a team player who can both take direction and show initiative as appropriate.
You are results-oriented, with an ability to manage multiple tasks simultaneously and expeditiously, have strong problem-solving skills and follow-through and a deep interest in working in the veterinary pharmaceutical space.
You’re not afraid of wearing multiple hats - you pitch in to help the team when necessary
You LOVE PETS and their people!
