Senior Operational Quality Assurance Specialist - 2nd Shift 1012

FLSA Classification: Exempt/Salary

Schedule: Monday - Friday; 1400 - 2230; On-Site (Eligible for one day of WFH per week after the successful completion of the 90-day probationary period).

Department: Global Quality Operations

Reports to: Operational Quality Assurance Manager

Supervisory responsibilities: No

Location: 13203 Murphy Road Suite 100 Stafford, TX 77477

Position Summary/objective:

The primary purpose of this position is to perform internal audits of manufacturing/CMC procedures; track and maintain standard operating procedures, work instructions, lab notebooks, manufacturing data and perform official batch and material release.

Essential functions:

• Oversee the batch release process for cell and gene therapy products, ensuring compliance with regulatory requirements, industry standards, and company policies.

• Review and approve batch records, analytical data, and associated documentation to ensure accuracy, completeness, and compliance with relevant regulations and guidelines.

• Conduct thorough quality checks on cell and gene therapy products, including verification of identity, potency, purity, and safety attributes.

• Collaborate closely with cross-functional teams, including manufacturing, quality control, regulatory affairs, and clinical operations, to address any quality issues, deviations, or non-conformances during batch release.

• Ensure appropriate corrective and preventive actions are implemented for identified quality issues and deviations.

• Maintain and update batch release procedures, protocols, and documentation in accordance with current regulatory guidelines and industry best practices.

• Provide guidance and support to junior members of the quality assurance team, including training, mentoring, and performance evaluation.

• Participate in internal and external audits, inspections, and regulatory submissions, providing necessary documentation and information.

• Contribute to the development and implementation of quality assurance strategies, policies, and procedures specific to cell and gene therapy products.

• Identify opportunities for process improvements, risk mitigation, and increased efficiency in the batch release process.

• Stay up to date with the latest advancements, regulations, and best practices in the field of cell and gene therapy manufacturing and quality assurance

• Ability to make sound decisions and approach problems with curiosity and open-mindedness

• High degree of independent working, analytical reasoning, and the ability to communicate effectively

• Careful editing and documenting of results

• Ability to embrace rapidly changing requirements with an open mind and show a high degree of flexibility in an environment which is marked by a constant striving for excellence

• Ability to approach tasks in a structured, reliable, and foresighted manner; combined with a high level of individual responsibility, enthusiasm, and strong social skills

• Ability to effectively collaborate with members from other departments

• Communicating Verbally - expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly.

• Hearing - the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds.

• Keyboarding - entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others.

• Lifting - raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object - usually by holding it in the hands or arms but may occur on the shoulder.

• Near Visual Acuity - clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).

• Pushing - Exerting force upon an object so that the object moves away from the object.

• Pulling - Exerting force upon an object so that the object moves toward the force.

• Sitting - remaining in a sitting position for at least 50% of the time.

• Standing/Walking - remain on one's feet in an upright position at a workstation.

• Stooping - occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles.

• The job title will be determined based on the candidate's qualifications and years of experience.

• Bachelor's degree in pharmaceutical sciences, life sciences, bioengineering, or a related field. A higher degree is preferred.

• Extensive experience (4+ years) in quality assurance, preferably within the cell and gene therapy industry, or biopharma with a focus in batch release

• At least 4+ years of Biotechnology and/or pharmaceutical industry experience is required.

• Strong knowledge of regulatory requirements and guidelines specific to cell and gene therapy products, such as FDA regulations, EMA guidelines, and ICH guidelines.

• Familiarity with relevant standards, such as cGMP (current Good Manufacturing Practice) and GCP (Good Clinical Practice).

• In-depth understanding of cell and gene therapy manufacturing processes, including cell culture, gene delivery systems, and viral vectors.

• Proficient in reviewing and interpreting analytical data, batch records, and technical documentation related to cell and gene therapy products.

• Experience in managing deviations, investigations, and CAPA (Corrective and Preventive Actions) processes.

• Excellent communication and collaboration skills, with the ability to work effectively across cross-functional teams and interact with regulatory agencies.

• Strong attention to detail, problem-solving abilities, and the ability to prioritize and manage multiple tasks simultaneously.

• Proactive mindset and a commitment to continuous improvement in quality assurance processes and practices.