866-274-4009 Contact Us

Supply Chain Quality Assurance Specialist/Senior Specialist

October 25, 2022

Summary

The Center for Breakthrough Medicines seeks an intrinsically motivated quality professional with a growth mindset who will meet and exceed deadlines and quality expectations.

The Supply Chain Quality Assurance Specialist/Senior Specialist will be accountable to provide quality oversight on compliance and Good Manufacturing Practice (GMP) that pertains to the end-to-end Supply Chain activities to meet CBM’s standards and regulatory expectations. These include quality support of materials management including receipt, storage, release, distribution, logistics, supplier complaints and internal investigations.

The role will provide timely decisions and consultations in alignment with cGMP, CBM and regulatory guidelines.

Responsibilities

  • QA support to the CBM Supply Chain end-to end materials management program, including processing of supplier complaints, material receipt and release, inventory control, shipping, and distribution.
  • Create material inspection plans in CBM’s internal inventory management system.
  • Escalate to Quality Management any quality and business risk(s) to CBM posed by materials suppliers.
  • Monitor and communicate supplier performance.
  • Manage supplier changes and impact evaluation to CBM.
  • Conduct, execute and document thorough investigations and CAPAs. Ensure timeliness of deliverables through proactive intervention. May own CAPA action items or deliverables.
  • Troubleshoot quality/compliance issues, using experience, ingenuity, and creativity to provide solutions to a wide range of root causes
  • Supports assessment and documentation of issues that might pose compliance risks, supporting investigation and solutions, and actions.
  • Maintain metrics
  • Support management reviews and other presentations
  • Maintain knowledge of regulatory environments, cGMPs, FDA policies and current industry trends.
  • Engage in cross functional organization to develop policies and processes to comply with new cGMP, USP, and CFR requirements/guidance at the site
  • Implement safety, quality and compliance improvement programs and initiatives. Innovate solutions to minor quality system gaps and participate in continuous improvement projects.
  • Responsible for revising established processes and procedures which may impact multiple functions or regions.
  • Performs other duties, as assigned

Qualifications

  • Bachelor’s Degree or higher
  • Specialist (3-5 years) and Senior Specialist (5+ years) of experience in cGMP supplier and materials management, preferably in a quality assurance role.
  • Strong knowledge of cGMP inventory management systems, particularly SAP.
  • Strong collaborator, internally and externally, with exceptional time management and organizational skills
  • Proven team player, with the ability and desire to grow within the CBM organization.
  • Excellent written and verbal communication skills
  • Excellent analytical, prioritization, multi-tasking, and communication skills.
  • Successfully drive projects forward to meet program/project deliverables
  • Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills
  • Ability to work effectively on cross functional teams

Physical Demands

  • Must have the ability to lift 25 – 50lbs
Contact Us Now

Technical Training Specialist – Training Academy

October 24, 2022

Summary

The Technical Training Specialist will report to the Sr. Manager of the Training Academy. Responsible for the administration of training in the CBM Training Academy. Provides technical support of GMP manufacturing operations. Works closely with department leadership to deliver a comprehensive “On the Job” training program that enables excellence in execution of manufacturing processes. Schedules new hire training module for Manufacturing and Testing and Analytics departments within CBM. The Technical Training Specialist is responsible for ensuring proper training and training compliance of the CBM staff to applicable SOPs, guidelines, and regulations within the Training Academy.

Responsibilities

  • Ensure all mandatory training requirements are executed as required
  • Partner with Department Training Coordinators and Supervisors to map out training plans for individual groups
  • Develop training aids such as visual aids, troubleshooting guides, manuals, and handbooks
  • Assist with identifying, developing, and implementing future improvements
  • Designs and applies assessment tools to measure training effectiveness
  • Act as Subject Matter Expert (SME) for specific technical areas (e.g. aseptic gowning, aseptic processing using a BSC, viral vector manufacturing, flow cytometry)
  • Schedules classroom or on-the-job training in a learning lab
  • Responsible for effective delivery of training to client group. Includes classroom, one-on-one, and on-the-job training.
  • Communicates training needs to local training management
  • Responsible for effective delivery of cGMP and other regulatory training, as required
  • Delivers initial and ongoing training for new hires and transfers.
  • Coaches and develops SME/qualified trainers within each department to be effective trainers
  • Collaborates with subject matter experts to support the development of OJT Task Evaluations and Instructor Led Courses.
  • Facilitates transition of new hires/transfer-ins from training environment to work environment
  • Identify internal and external training programs to address competency gaps, as needed

Qualifications

  • Bachelor’s degree in a Science discipline, or equivalent experience
  • Train the Trainer Certification desired but not required
  • Prior hands-on experience with equipment and unit operations typically used in process development and manufacture of cell therapy products is preferred
  • 4+ years in manufacturing operations in a GMP/BioPharma environment
  • Training delivery experience required.
  • History of maintaining personnel training and performance metrics.
  • Strong knowledge of cGMP regulations and quality management systems.
  • Working knowledge of MS Word, PowerPoint, Excel, and Outlook.
  • Excellent written and verbal communication and interpersonal skills.
  • Exhibits attention to detail, accuracy in work, and integrity of character.
  • Possesses aptitude to learn and operate equipment and apply emerging learning technologies.
  • Able to adhere to all safety and company regulations.
  • Able to accommodate a flexible work schedule to support business demands.

Physical Demands

Physical Requirements:

  • Ability to carry up to 55 pounds.
  • Ability to stand for long periods of time while wearing various levels of PPE daily
Contact Us Now