Job Description

Description

JOB SUMMARY

Precision Science, a contract manufacturer of Animal Health FDA and EPA regulated products, is seeking an

experienced individual to lead the Quality Assurance Team and will report to the QA/QC Director. This position

will require an efficient, dynamic, agile, and hands-on individual interested in building relationships internally and

externally with the company, including with customers and vendors, to ensure the delivery of quality products.

Additionally, the successful individual will provide day-to-day management of the Quality Assurance functions

including oversight of QA; work with functional groups to provide direction and appropriate solutions for

compliant operational practices; drive decision making and issue resolution and advise management on areas of

regulatory / business risks related to quality assurance activities. The individual will be responsible for the

development of the QA staff and will work cohesively with the other tactical leadership functions to drive

improvements , efficiencies and to meet the overall business objectives.

ESSENTIAL FUNCTIONS:

• Maintain current knowledge of regulatory requirements/trends to ensure that expert advice and

appropriate technical support on quality matters is provided to the company.

• Responsible for the design, implementation, monitoring and compliance of the internal quality system,

policies and procedures to ensure that all products meet specifications and customer requirements.

• Ensure all aspects of receiving, handling, development, manufacturing and distribution of products

comply with contract manufacturing agreements and meet relevant cGMP, regulatory and customer

requirements.

• Support and ensure compliance of product and process transfers, including validation, from and/or to

other manufacturing sites and the establishment of KPIs across the business.

• Leads coordination and preparation of activities related to regulatory agency inspections.
• Ensure that quality assurance operates in a cost effective and efficient manner and maintains an

innovative approach based on productivity improvement, implementation of best practice and

harmonization across functional teams.

• Provide leadership, direction, and support to the people within the department and ensure that they are

qualified, achieve a high level of competence, are motivated, have opportunities for development and

they deliver on their responsibilities and commitments.

The above statements are intended to describe the general nature and level of work being performed by

employees in this position. This is not intended to be an exhaustive list of all responsibilities.

Requirements

EXPERIENCE:

•  At least 10 years’ experience in the pharmaceutical industry in a Quality Assurance or Regulatory Compliance role.
• Relative QC experience is a plus
• Requires current and strong working knowledge of cGMP and FDA (CFR 211, CFR 225, CFR 226).
• Experience with EPA regulated products a plus.
• Experience in developing, tracking, and reporting KPIs and manufacturing metrics.

EDUCATION / TECHNOLOGY SKILLS:

• Requires a Bachelor’s or Master’s degree in a scientific discipline.
• Professional certification in quality, compliance or regulatory affairs a plus.
• Proficiency with MS Office, electronic systems and databases.

Precision Science is An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, genetic information or protected veteran status.