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.

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 below 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. Unsolicited resumes for these positions will be considered to be free referrals.

PURPOSE 

Primary role is to supports manufacturing and quality operations to ensure compliance with cGMP, FDA, and applicable regulatory requirements. This role is responsible for maintaining and improving quality systems, supporting investigations and CAPAs, and partnering with cross-functional teams to ensure the consistent manufacture and release of high-quality pharmaceutical products.

REPORTS TO

Reports to the Quality Control Manager and supports the Quality Control organization. This role will interact with cross-functional departments including Manufacturing, Research and Development, Analytical Development, Quality Assurance, and Facilities, as well as external vendors and service providers, to support Quality Control operations, equipment, and quality system activities.

DUTIES AND RESPONSIBILITIES

• Author, execute, and maintain equipment qualification protocols and reports (IQ/OQ/PQ as applicable) in support of Quality Control laboratory operations.
• Author, execute, and maintain cleaning validation protocols and reports for equipment and laboratory areas, ensuring compliance with cGMP and internal requirements.
• Support the Quality Control organization in the management of quality system records, including change controls, CAPAs, deviations (DEVs), and out-of-specification (OOS) investigations, ensuring timely, thorough, and compliant documentation.
• Participate in and support root cause investigations, risk assessments, and the development of effective corrective and preventive actions.
• Coordinate with internal stakeholders and external vendors to ensure laboratory equipment calibration activities are completed accurately and within required timelines.
• Develop, revise, and maintain SOPs, work instructions, and processes related to equipment qualification, validation, calibration, and quality systems.
• Provide quality engineering support to operations to maintain a state of control and readiness for internal, client, and regulatory inspections.
• Review and assess the impact of proposed changes on systems, equipment, and processes, and support implementation through the change control process.
• Ensure documentation and activities comply with cGMP, FDA regulations, data integrity principles, and company policies.
• Collaborate cross-functionally with Quality Assurance, Manufacturing, R&D, Analytical development, and other stakeholders as required to support company objectives.
• Identify opportunities for process improvement within quality systems and contribute to continuous improvement initiatives.

QUALIFICATIONS (Education, Experience, Knowledge, and Skills)

• Bachelor’s degree or higher in a life or chemical science; chemical engineer, chemistry, analytical chemistry, or a similar science-based degree preferred.
• Minimum of five years of experience in Quality Control within a pharmaceutical, chemical, or manufacturing environment, with at least two years of experience in a validation or quality engineering role.
• Strong knowledge of cGMP, FDA, ICH, and USP requirements.
• Hands-on experience with analytical techniques.
• Strong technical writing skills with a quality-oriented mindset, and a proven ability to author and execute protocols in laboratory and manufacturing environments.
• Strong interpersonal skills, with a demonstrated ability to work effectively, professionally, and respectfully in a team-based environment, and to collaborate with peers, customers, line management, and technical subject matter 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 below 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. Unsolicited resumes for these positions will be considered to be free referrals.