As an industry leader, with over 60 plasma collection centers throughout the United States, CSL Plasma can provide you with an exceptional opportunity to learn and experience a diverse variety of jobs that are truly rewarding.  We are passionate about setting and maintaining the highest standards in every aspect of our organization, and we believe this begins with our employees.

CSL Plasma is looking for qualified healthcare professionals that will help identify, screen and prepare eligible plasma donors. We are looking for Medical Reception, Phlebotomy, Nurses (LVNs, LPNs, RNs), Paramedics, Physicians, Compliance/Quality Specialists and Management positions.  Both part time and full time positions may be available.

Quality Process Engineer

CSL Plasma (formerly ZLB Plasma) has an immediate opening for a Quality Process Engineer who will be responsible for facilitating the development, definition and improvement of the Corrective and Preventive Action (CAPA) and Deviation Resolution and Change Control processes.  Develops and maintains a documented Failure Mode Effects Analyses (FMEA) of key Plasma collection processes. Assesses the risks associated with those failure modes and maintains a database that documents root causes and resolutions.

 

Other responsibilities include:

• Maintains an excellent state of compliance for on time closures for deviations, CAPAs, and internal audits.
• Manages projects effectively with an emphasis on multi-tasking and the ability to meet deadlines with quality results.
• Leads and participates on cross-functional teams to meet project and other deadlines associated with Quality and Operational performance objectives.
• Updates FMEA when complaints, non-conformances, and deviations occur.
• Trains all users of the CAPA process.
• Defines and controls all of the inputs into the CAPA system to improve the quality of root cause investigations and reduce the recurrence of quality issues.
• Gathers subject matter experts together to define the risks associated with pre-defined failure modes and develops methods to address each class of risk.
• Assures all process changes are entered into the system, analyzed for risk and impact, and plans are executed and approved.
• Mentors others on Data Analysis / Management Skills, technical problem prevention and resolution, design control procedures, investigation process, and methods to arrive at true root causes.
• Quickly engages with individuals involved in problems who need facilitation through to successful resolution.  Enables them to help themselves in future challenges through use of a disciplined approach to troubleshooting and documentation of steps taken.
• Plans, prepares, and reviews validation activities and summary reports for team members and self.
• Maintains a thorough understanding of the following regulations and guidelines: Food & Drug Administration (FDA); current Good Manufacturing Practices (cGMP); corporate policies and procedures; FDA's guidance on Validations; all related Medical Device Directives; and other applicable standards.

 

Successful Candidates Offer:

• Bachelor’s degree in engineering, science, or related field, or equivalent combination of relevant work experience and education required.
• Two (2) years experience as a Quality Engineer, Scientist or equivalent in an industry regulated by the Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH) or Center for Drug Evaluation and Research (CDER) or similar.
• Demonstrated ability to analyze process failures and write concise technical reports of problem identification and resolution successfully within a regulated industry.
• Demonstrated ability to create a process, document (i.e. write Standard Operating Procedures (SOPs)) and validate it for use by trained individuals. 
• Statistical analysis experience preferred.
• Previous experience either leading or participating on FMEA development teams.
• Ability to lead teams without the benefit of a direct reporting relationship.
• Strong computer skills, including Microsoft Outlook, Word, Excel, PowerPoint, and Project.
• Ability to teach methods of analysis and written reporting to trained, but non-engineering staff with enthusiasm, compassion and effectiveness.
• Excellent critical reasoning, decision-making, and system thinking skills.
• Ability to perform statistical evaluations of data.

CSL Employees Enjoy:

Health Insurance Programs

• Medical, Dental, Vision and Life Insurance
• Domestic Partner Benefits
• Short-term & Long-term Disability

Work and Life Balance Programs

• Company paid and Personal holidays
• Paid Time Off (3 weeks in first year)
• Leave Programs
• Wellness Reimbursement
• Employee Recognition Programs

Personal and Career Development

• Tuition Assistance
• Promotional Opportunities

For consideration please APPLY NOW or visit  http://www.cslplasma.com /and click on "Careers" and follow the Career Opportunities links. Please then choose the position and location you are applying for.  You will be able to review and apply to our current job openings, as well as create your online profile.

 

DFWP, EOE