Quality Control Manager

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Job Description

What we believe

Texas A&M University is committed to enriching the learning and working environment for all visitors, students, faculty, and staff by promoting a culture that embraces inclusion, diversity, equity, and accountability. Diverse perspectives, talents and identities are vital to accomplishing our mission and living our core values .”

Who we are

As one of the fastest-growing academic health centers in the nation, the Texas A&M University Health Science Center encompasses five colleges and numerous centers and institutes working together to improve health through transformative education, innovative research and team-based health care delivery.

What we want

The Health Science Center (HSC) is looking for a Quality Control Manager to serve as a member of the Center for Innovation in Advanced Development and Manufacturing (CIADM) team. We desire an individual who subscribes to and supports our commitment as stated above. The successful applicant will bring an expert level of quality control experience to the position and understand the demands of supporting executives in a fast-paced environment. This person must be professional, enjoy working in a high-volume environment and be able to apply strong organizational skills while being flexible in their daily routine. If this is you, we invite you to apply to become a member of our team.

Required Education and Experience:

• Bachelor of Science degree in life sciences preferably Biochemistry, Microbiology, Chemistry, or other related technical field.
• Six years’ Quality Control work-related experience in a biopharmaceutical or pharmaceutical cGMP manufacturing environment. Three years minimum supervisory experience managing direct reports.

Required Knowledge, Skills and Abilities:

• Experience and knowledge of GMP, GLP and FDA requirements and documentation.
• Experience in planning, organizing, coordinating, managing and directing QC activities including documentation, training, environmental monitoring oversight, generation and review of quality documents.
• Experience with a variety of analytical and microbiological instrumentation for supporting process development and GMP production including aseptic filling/finishing and media fills.
• Expertise in aseptic techniques and the handling and maintenance of microbial strains and mammalian cell lines.
• Expertise for conducting, reviewing, analyzing and trouble-shooting experiments relevant to assay development and qualification.
• Experience in managing, training and maintaining well-trained staff.
• Experience in SOPs and TMs development.
• Self-directed with the ability to multi-task, organize, prioritize and work cooperatively with others.
• Strong verbal and written communication skills, with the ability to keep detailed and up-to-date records and to present information clearly and concisely.
• Effective interpersonal and organizational skills.

Preferred Education and Experience:

• Bachelor of Science degree in Life Sciences preferably Biochemistry, Microbiology, Chemistry, or other related technical field.

Preferred Experience:

• Three years of supervisory experience managing direct reports with six years’ Quality Control work-related experience in a regulated laboratory environment in support of a biopharmaceutical, pharmaceutical or medical device manufacturing operation .

Responsibilities:

• The major responsibilities are to lead and manage a drug quality control laboratory performing research and development that achieve the goals of projects and the institution, and to collaborate with principal investigators and clients. Quality control activities for evaluating quality profiles and characterization of new drugs are required for getting approvals of new drug applications from the FDA for testing in clinical trials.
• This position will also need:
• To plan, and organize QC analytical and microbiological testing portion of projects and establish the required procedures to be applied to those projects.
• Direct QC staff and daily operations to prioritize workload and assure turnaround times are met for raw materials release, in-process testing, QC documentation, and QC equipment maintenance and calibration.
• Implement and follow good documentation practices in all aspects and phases of QC testing. Ensure reports and other documentation prepared by QC are reviewed and approved for accuracy and data integrity in a timely manner.
• Provide technical knowledge and leadership to QC personnel to support routine analytical and microbiological testing.
• To conduct analytical and microbiological testing portion of projects.
• To define problems and provide possible solutions as dictated by projects and protocols.
• To develop and modify applications and equipment applications to accomplish project goals, as required.
• To train and supervise staff.
• To coordinate and provide technical direction to research staff to ensure effective and cost-efficient completion of projects if needed.
• To provide technical knowledge to staff to ensure completion their assignments.
• To analyze, interpret, compile and report project results to the supervisor and/or management.
• To provide finished oral and written communication reports to the supervisor and management.
• To work under GLP/GMP to provide high quality, regulatory compliant technical documentation.
• To review and approve data, procedures and testing in support of final release of materials, process intermediates, final products.
• To ensure QC personnel is fully trained.
• To ensure the QC lab is maintained in a state of compliance with quality systems procedures and policies, applicable SOPs and cGMP and GLP requirements, and the department safety and housekeeping agendas are sustained.
• To facilitate or coordinate lab qualification activities, as needed.
• Other duties, work and duties as assigned to support compliance. Preparation of SOPs, TMs, reports, and other QC-related documents.
• Review of SOPs, TMs, reports, and other QC-related documents.
• Maintenance of appropriate documentation for tests, research and development as specified by the QC department and required laws and regulations.
• Preparation and reporting of monthly metrics and trending for worked performed within the department, as needed.
• Performs other duties as assigned.

Instructions to Applicants: Applications received by Texas A&M University must either have all job application data entered or a resume attached. Failure to provide all job application data or a complete resume could result in an invalid submission and a rejected application. We encourage all applicants to upload a resume or use a LinkedIn profile to pre-populate the online application

All positions are security-sensitive. Applicants are subject to a criminal history investigation, and employment is contingent upon the institution’s verification of credentials and/or other information required by the institution’s procedures, including the completion of the criminal history check.

Equal Opportunity/Affirmative Action/Veterans/Disability Employer committed to diversity.