Quality Control Supervisor - Round Rock - Benuvia

Description

PURPOSE

Primary role is to lead Quality Control laboratory operations to ensure compliance with cGMP, FDA, and regulatory requirements in support of pharmaceutical manufacturing. This role provides leadership and direction to the Quality Control team in testing, data integrity, approval and release of raw materials, in-process samples, intermediates, and finished drug products.

Ensure you read the information regarding this opportunity thoroughly before making an application.

REPORTS TO

Reports to the Quality Control Manager and oversees a team of Quality Control Chemists and Technicians. This position will also interact with other departments including Quality Assurance, Analytical/ Stability, API, Research & Development, Business Development and outside vendors.

DUTIES AND RESPONSIBILITIES

Laboratory Operations

• Ensure a safe working environment by providing leadership on all safety-related issues in the quality and microbiology laboratories at the Round Rock site.
• Be an active champion for good housekeeping, cGMP and safety related issues.
• Maintain and develop strategy for the analytical equipment and instrumentation in both labs.
• Ensure the spare parts program is in place for instrumentation.
• Ensure analytical methods are maintained and validated.
• Coordinate internal and external laboratory tests, procedures and methods and the development of new product test methods and specifications in conjunction with manufacturing, marketing, product development and sales functions.
• Ensure that all finished product meets appropriate internal specifications to ensure customer satisfaction.
• Handle special projects assigned for method validations or equipment qualifications.
• Ensure necessary supplies are ordered and stocked for the laboratory operations.

Leadership & Team Development

• Supervise the quality department chemists, analysts, and technicians. Manage in accordance with the organization's policies and applicable laws.
• Mentor and train employees; planning, assigning, and directing work.
• Support employee development through training and performance management.
• Managing complaints and resolving performance and collaboration issues.

Compliance & Documentation

• Ensure laboratory operations comply to relevant standards: GMP, GDP, ISO 9001:2015.
• Ensure instrumentation is compliant with current standards and follows recommended calibration frequencies and/or replacement schedules.
• Ensures proper compliance to OOS program and proper investigations are completed and documented.
• Participate in internal audits and conduct audits of the laboratory operations to ensure compliance is demonstrated.

Continuous Improvement

• Identify opportunities for process improvements within the laboratory.
• Implement efficiency initiatives and best practices.
• Support method validation, method transfer, and analytical troubleshooting.

QUALIFICATIONS (Education, Experience, Knowledge, and Skills)

• Bachelor's degree or higher in a Life or Chemical Science; Chemistry, Analytical Chemistry or similar science-based degrees preferred.
• Minimum of 5 years in Quality Control within a pharmaceutical, chemical or manufacturing environment with a minimum of 2-5 years of experience in a supervisory or management role.
• Strong knowledge of cGMP, FDA, ICH, and USP requirements
• Hands-on experience with HPLC, GC, spectroscopy, wet chemistry, and other analytical techniques.
• Demonstrated ability to lead and develop teams and resolve conflicts in support of organizational goals.
• Strong interpersonal skills: demonstrated ability to work effectively, professionally, and respectfully in a team-based environment to involve peers, customers, line management and technical competency experts.

WORKING CONDITIONS / PHYSICAL REQUIREMENTS

• Ability to stand for up to 8 hours per day.
• Frequent sitting, standing, walking, reading written documents and use of computer monitor screen, talking, writing, listening.
• Occasional climbing ladders/steps, walking up inclines and uneven terrain, reaching with hands and arms, stooping, kneeling, crouching, crawling, twisting, bending, handling, turning, balancing, carrying, grasping.
• Occasional lifting and/or moving up to 50 pounds.

LOCATION

This position requires to be onsite in Round Rock, Texas. Rock Round is located 15 miles north of Austin.

TO APPLY

If you are interested in joining the Benuvia team, please SUBMIT YOUR RESUME along with your salary requirement.

Applicants must be legally authorized to work in the U.S. Visa sponsorship is not available at this time.

Positions posted for Benuvia Operation are not intended for or open to third party recruiters or agencies. xhmxlyz Unsolicited resumes for these positions will be considered to be free referrals.