Bioprocess Manufacturing QA Lead

Job description

3096269
City

Marlborough
Career Level

Experienced
Relocation Assistance

Yes
Business

GE Healthcare
Business Segment

Healthcare Quality
Function

Quality
Country/Territory

United States
U.S. State, China or Canada Provinces

Massachusetts
Postal Code

01752-7217
Role Summary/Purpose

This position is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. This is a key technical role responsible for the development, 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. Lead and support key QA/RA activities as assigned including Corrective Action Preventative Action investigations, Training,and Internal Auditing
2. Review/approve Assay Qualification protocols, qualification reports and associated data and stability protocols/reports and data in support of production of API product
3. Assist with review of API release testing in support of product disposition as required
4. Identify and report any quality or compliance concerns and take immediate corrective action as required
5. Leads process efficiency and compliance effectiveness through the development and implementation of process verification and validation plans
6. 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)
7. Ensure regulatory compliance and optimization of quality system procedures relating to cGMP processes, maintenance and improvement of documented processes, development and implementation of employee training, and development and implementation of quality metrics to drive improvement and business results
8. Perform broad variety of tasks in support of product and process design as required by the departmental leadership

Quality Specific Goals:
1. Continue to develop a working knowledge of, and train others on, 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. Conduct mock audits to assess responsible functions and processes and identify areas for improvement/increased compliance
3. Maintain compliance to Quality System Regulation (QSR) and Current Good Manufacturing Practices (cGMP) requirements by supporting successful internal audits, assist in the reduction of significant audit findings from previous inspections and helping prevent repeat findings from previous GAC audits
4. Provide direction and guidance to peers and subordinates to assist with their learning and effectiveness
Qualifications/Requirements

1. Bachelor's Degree or a minimum of 4 years work experience.
2. Minimum of 1 year experience working in a regulated industry or a Masters degree
3, Experience in a pharmaceutical industry
4. Experience with CAPA systems, Deviations, Nonconformance
5. Experience applying regulations (including FDA cGMP)
6. Ability to communicate effectively (both written and oral) in English
Desired Characteristics

1. Minimum of 3 years experience in a regulated industry is preferred
2. Demonstrated understanding or aptitude to understand Pharmaceutical QMS requirements and regulatory requirements including by not limited to FDA 21CFR 210, 211 and ICH Q10.
3. Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes
4. Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.
5. Demonstrated collaboration, negotiation & conflict resolution skills
6. Excellent communication skills (written and oral)
7. Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
8. 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 medical device environment.
9. Demonstrated understanding of continuous quality / process improvement tools: (As defined by the local site, e.g. DMIAC, SPC, Lean SS, 5S)
10. Experience leading and implementing change
11. Experience performing internal audits and participating in external audits
12. Exceptional analytical, problem solving & root-cause analysis skills
13. Ability to multi-task & handle tasks with competing priorities effectively
14. Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.
About Us

There is no other life sciences company quite like GE Healthcare Life Sciences. A $5 billion business with more
than 11,000 individuals in over 100 countries, we are at work enabling a new era in medicine. For more than 60
years, GE Healthcare Life Sciences has globally supported the development and use of new therapies, helping
accelerate the journey from biological understanding to clinical therapy. GE Healthcare Life Sciences works with
cutting edge technology enabling and advancing the discovery, diagnosis and medical treatments of the present
and the future. We are accelerating biology to cell therapy in ways no other company can.
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GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is anEqual Opportunity Employer . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
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 drug screen.