Quality Assurance Manager

Company Overview

BC US LLC, established in 2012 near Immokalee, Florida, is dedicated to providing high-quality care and enrichment for Mauritian origin macaques. Our facility supports life-saving biomedical research programs by supplying non-human primate models to pharmaceutical companies, CROs, and universities.

Summary

We are seeking a Quality Assurance Manager to join our team at BC US LLC.The Quality Assurance (QA) Manager will oversee the activity of the quality assurance department and staff, developing, implementing, and maintaining a system of quality and reliability testing for the organization’s processes. Ensuring the business maintains compliance with all applicable Federal, State, Local, and Industry regulations and standards.

Responsibilities

• Responsible for ensuring the Company is compliant with all applicable regulations (Local, State, Federal, OSHA and other applicable agencies) and internal policies.
• Provide guidance and mentor direct reports to grow the QA department.
• Develop, operate, and maintain the effectiveness of the Quality Management System, the processes/procedures; Document Control, Deviations, Change Control, Internal Auditing, and Quality Management Review.
• Conduct internal audits and report results to site leadership.
• Lead Process Improvement activities within the QA department and across other departments to streamline and improve existing processes to eliminate non-value-added activities.
• Communicate all quality related issues and trends to site leadership and provide periodic reports on quality assurance matters.
• Support regulatory inspections and draft/coordinate responses (if required) to ensure the site is compliant with regulatory requirements.
• Maintain the approved supplier list and ensure all materials received and services performed are from approved suppliers and conform to specifications.
• Communicates quality standards and parameters to QA team and other appropriate staff.
• Reviews client/ customer feedback on processes and partner with the appropriate team if changes are needed.
• Performs other related duties as assigned.

Qualifications

• Bachelor’s degree in life sciences, engineering, or related field. Advanced degree preferred.
• 3 years of proven experience of Quality Management experience.
• Process improvement/Lean Six Sigma/Agile methodology experience preferred.
• Strong working knowledge of global GMP/GLP requirements, regulations, and guidance.

REQUIRED SKILLS/ABILITIES

• Ability to work effectively with cross-functional teams
• Excellent leadership, communication, and interpersonal skills.
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively as part of a multidisciplinary team.
• Proficiency in MS Office Suite.
• Excellent time management skills with a proven ability to meet deadlines.
• Excellent organizational skills and attention to detail.
• Bilingual in English and Spanish preferred.

PHYSICAL REQUIREMENTS

• Prolonged periods of sitting at a desk and working on a computer
• Must be able to lift 15 pounds.
• Ability to work for short periods of time in Florida outdoor conditions.

If you are passionate about ensuring the highest standards in biomedical research and animal care, we invite you to apply today and become an integral part of our team at BC US LLC.

Job Type: Full-time

Pay: $85,000.00 - $95,000.00 per year

Benefits:

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

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to Commute:

• Immokalee, FL 34142 (Preferred)

Ability to Relocate:

• Immokalee, FL 34142: Relocate before starting work (Required)

Work Location: In person

Salary : $85,000 - $95,000