Senior Technical Operations Support Specialist
On-siteSugar Land, Texas, United States
Job Summary
Drive continuous process improvement in sterile-to-sterile compounding operations while serving as the subject matter expert in production materials, components, and equipment flow. Evaluate product codes to identify campaign manufacturing opportunities, develop batch record templates and BOMs, and generate change control documentation for new products or process improvements. Support compounder training, update Standard Operating Procedures, and create knowledge transfer plans for new processes. Represent operations in investigation and documentation of process-related Notice of Events and Variances, while providing visibility of shop floor concerns to Quality Partners, Commercial Operations, and Executive Management.
Required Qualifications
- Legally authorized to work in the job posting country
- Minimum of a Bachelor's Degree
- Relevant certifications including Gowning Qualification, Aseptic Operator Simulation Certification, PTCB Certification (CPhT), and ACPE Sterile Certification
- Minimum 5 years' experience in sterile-to-sterile compounding operations, and distribution of sterile pharmaceutical products
- Experience in the supervision of daily compounding operations
- An in-depth knowledge of the intricacies specific to various product codes and process types
- Extensive knowledge of cGMPs and aseptic techniques
- Good working knowledge of regulatory guidance as it pertains to sterile-to-sterile compounding operations
- Experience in Aseptic Operator Qualification and Process Simulation
- Knowledge of personnel and material flow patterns required for sterile environments
- Ability to sit and/or stand 8 hours or more per day if needed
- Ability to manipulate necessary office equipment, computer software, hardware & equipment
- Ability to perform the following physical activities: stooping, reaching, standing, grasping, walking, feeling, talking and hearing
Desired Qualifications
- Strong problem-solving skills, including use of the scientific method
- Strong analytical skills
- Ability to make decisions in a constantly changing environment
- Demonstrated interpersonal communication skills
- Proficient in technical writing
- Microsoft office including Word, Excel, PowerPoint
- Ability to motivate cross functional teams to meet aggressive timelines
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