QC Manager

Baxter•Jayuya, PR

About The Position

As the QC Manager, you will lead and organize the operations of the Microbiology and Chemistry Laboratories. You will work closely with Manufacturing, Supply Chain, Quality, Regulatory, and R&D teams to ensure laboratory testing activities are executed in compliance with FDA regulations, USP standards, company policies, and current Good Manufacturing Practices (cGMPs). This role is responsible for the development and implementation of laboratory policies, systems, procedures, specifications, and testing programs for Raw Materials, In-Process Materials, Finished Products, Stability Programs, and Method Transfers. You will also oversee laboratory validation activities, quality monitoring programs, and change control processes to support business priorities, quality objectives, and operational excellence.

Requirements

Bachelor's degree in Chemistry, Microbiology, or a related scientific discipline.
Minimum of 8 years of experience in Quality Systems within a regulated environment.
Minimum of 3 years of management or supervisory experience in a laboratory setting.
Experience with wet chemistry and/or microbiology laboratory procedures.
Root Cause Analysis training and practical experience.
Working knowledge of applied statistics and statistical tools.
Strong understanding of FDA regulations, USP standards, cGMPs, laboratory operations, and quality systems.
Experience with laboratory validation programs, method transfers, and stabil
Proven ability to train, motivate, coach, and develop employees.
Strong presentation and communication skills.
Demonstrated success in change management and leading organizational change.
Demonstrated commitment to integrity, accountability, teamwork, collaboration, and performance excellence.
Strong facilitation and conflict resolution skills.
Fully bilingual in English and Spanish.
Ability to effectively communicate and present information to management, customers, and regulatory auditors.

Responsibilities

Direct and manage all Microbiology and Chemistry Laboratory operations.
Coordinate laboratory activities with Manufacturing and Supply Chain teams.
Lead, supervise, train, and develop exempt and non-exempt laboratory personnel.
Ensure laboratory services are delivered efficiently, cost-effectively, and in compliance with applicable regulations and standards.
Perform weekly, monthly, and annual reporting as required by site leadership and company procedures.
Ensure compliance with all applicable FDA, USP, OSHA, EPA, cGMP, corporate, federal, and state requirements.
Establish, implement, and maintain laboratory standard operating procedures and policies.
Conduct and approve laboratory investigations, including root cause analysis activities.
Conduct trend analysis, including Annual Product Review data evaluations.
Ensure all laboratory changes are appropriately managed through the change control system.
Maintain accountability for the Product Stability Program.
Manage the laboratory validation program, including equipment, processes, test methods, software, and related systems.
Lead and support method transfer activities where applicable.
Participate in process validation and revalidation programs.
Oversee testing and analysis of validation samples.
Support continuous improvement initiatives through laboratory automation and testing method enhancements.
Ensure laboratory analysts are properly trained and qualified to perform testing activities.
Verify adherence to Good Laboratory Practices, company standards, and regulatory requirements.
Routinely audit analyst performance, testing accuracy, and documentation practices to assess training effectiveness and compliance.
Develop and manage departmental operating and capital budgets.
Maintain laboratory technologies, software, and equipment in an updated state.
Prepare and submit capital expenditure requests as needed.
Ensure all laboratory service contracts are maintained and current.
Evaluate and manage laboratory maintenance service suppliers.

Benefits

medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
educational assistance programs
paid holidays
paid time off ranging from 20 to 35 days based on length of service
family and medical leaves of absence
paid parental leave
commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
childcare benefits