This position is responsible for providing GMP manufacturing process support in accordance with documented procedures and practices. This is a technical role responsible for the implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business. The role involves hands-on work in the areas of design, design transfer, manufacturing, distribution, and/or service. Essential Responsibilities 1. Assists in ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
2. Communicates & implements a strategy to ensure compliance.
3. Responsible for review of Batch records in support of disposition of bulk drug substance
4. Responsible for review of equipment validation protocols and report
5. General compliance quality systems management support for the following areas:
- Raw material and solution release
- Review of raw material specifications and solution documents
- Release of Single Use Disposable product to include label reconciliation
- Review of temperature charts and documentation of temperature related excursions
- Review and update label issuance and reconciliation process
- General QA Documentation support to include the following:
- Issuance of batch records & issuance & tracking of logbooks, lab notebooks & SOP binders
- Scanning and filing of excursion documentation and client related batch documentation to support batch release
6. Develops process improvement plans using a variety of Quality and Continuous Process Improvement tools, including but not limited to Six Sigma, Lean Manufacturing, 5S, SPC, engineering studies, DOE, Gauge R&R, etc.
7. Supports continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program).
8. Ensures process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
9. Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.
Quality Specific Goals:
1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
2. Complete all planned Quality & Compliance training within the defined deadlines.
3. Identify and report any quality or compliance concerns and take immediate corrective action as required
1. Bachelor's Degree or a minimum of 7 years work experience.
2. 5 years experience working in a regulated industry
3. Demonstrated understanding or aptitude to understand Drug or Pharma QMS requirements and regulatory requirements including but not limited to FDA CFR 21 210 and 211.
4. Ability to communicate effectively in English (both written and oral).
5. Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications. Additional Eligibility Qualifications GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen. Desired Characteristics 1. 7 years experience in a regulated industry is preferred
2. Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes
3. Demonstrated expertise to effectively communicate within all levels of the organization around concepts of validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as Six Sigma, etc.
4. Demonstrated collaboration, negotiation & conflict resolution skills
5. Excellent communication skills (written and oral)
6. Demonstrated ability to acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
7. Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a drug/biologics environment.
8. Demonstrated understanding of continuous quality / process improvement tools: (As defined by the local site, e.g. DMIAC, SPC, Lean SS, 5S)
9. Experience leading and implementing change
10. Experience performing internal audits
11. Exceptional analytical, problem solving & root-cause analysis skills
12. Ability to multi-task & handle tasks with competing priorities effectively
13. Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures).
14. Prior GE Healthcare experience