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CAPA Process Analyst II

KYYBA, Inc

Gretna, LA

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JOB DETAILS
SKILLS
Agile Programming Methodologies, American Society for Quality (ASQ), Biology, Biotech and Pharmaceutical, Business Services, Clinical Laboratory, Communication Skills, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Documentation, Establish Priorities, External Audit, FDA (Food and Drug Administration), Information Technology & Information Systems, Information Technology/Systems Audit, Internal Audit, Interpersonal Skills, Laboratory, Laboratory Operations, Legal, Medical Equipment, Pathology, Presentation/Verbal Skills, Procedure Development, Process Analysis, Project/Program Management, Quality Management, Quality System Requirements (QSR), Record Keeping, Regulations, Regulatory Requirements, Root Cause Analysis, Systems Maintenance, Technical Operations, Technical Recruiting, Technical Writing, Time Management, Toxicology, Trend Analysis, Writing Skills
LOCATION
Gretna, LA
POSTED
30+ days ago
Job Title:CAPA Process Analyst II
 
About Kyyba:
Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.
At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development. 
 
Job Description
  
Years’ Experience: 4+ Years
 
The CAPA Process Analyst II:
  • Conducts investigations of nonconformances/quality events and progresses the associated quality records through ***’s QMS platform in accordance with established procedures.
  • Collaborates with cross-functional teams to support investigations and ensure corrective actions are appropriate.
  • Ensures that corrective and preventive actions are appropriate, accurately and completely documented, implemented on time, and meet the required procedural and regulatory standards.
  • Interacts cross-functionally, ensuring that all communications, interpersonal interactions, and business behaviors are consistent with the *** Code of Conduct.
 
Main Responsibilities:
  • Leads the investigation of complex and highly technical quality issues and ensures the timely completion of CAPA system activities initiated to address nonconformances, potential nonconformances, deviations, and/or complaints.
  • Executes investigations and CAPAs in accordance with established procedures, ensuring consistency with quality system requirements.
  • Serves as a subject matter expert in conducting investigations and performing root cause analysis to ensure that root and potential causes are appropriately identified and mitigated/eliminated.
  • Collaborates with laboratory operations and technical staff to conduct investigations and ensure corrective actions are appropriate and effectively implemented.
  • Maintains CAPA system records to ensure audit-readiness for internal and external quality system audits.
  • Ensure CAPA documentation is accurate, well-structured, and compliant with procedural requirements and regulatory guidelines.
  • Supports the initiation and implementation of improvement activities associated with identified trends.
  • Escalates potential compliance risks, quality concerns, or procedural gaps to the Quality Manager to ensure timely evaluation and resolution.
  • Demonstrates effective written and verbal communication skills.
  • Prioritizes workload in relation to business needs.
  • Supports the attainment of *** Toxicology Laboratories' goals and objectives.
  • Performs other duties as assigned by the Quality Manager.
 
 
Required Qualifications:
  • Bachelor’s degree in Life Sciences
  • Experience with Corrective and Preventative Action process in regulated environments, pharmaceuticals medical devices or laboratories
  • Excellent communication and technical writing skills
  • Experienced in working with QMS platforms
 
 
Preferred Qualifications:
  • ASQ CQA
  • Project management experience
  • Knowledge of College of American Pathologists (CAP) regulations, NLCP regulations, or similar regulations (i.e., FDA).
  • Experienced in navigating Agile
 
Location: (Gretna, LA)
 
Disclaimer: 
Kyyba is an Equal Opportunity Employer.
Kyyba does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, ag e, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. Minorities / Females / Protected Veterans / Individuals with Disabilities are encouraged to apply. All employment is decided on the basis of qualifications, merit, and business need.”
It is the policy of Kyyba to provide reasonable accommodation when requested by a qualified applicant or employee with a disability, unless such accommodation would cause an undue hardship. The policy regarding requests for reasonable accommodation applies to all aspects of employment, including the application process. If reasonable accommodation is needed, please contact Kyyba at 248-813-9665


Rewards:
Medical, dental, vision
401k 
Term life
Voluntary life and disability insurance
Optional Pre-paid legal plan
Optional Identity theft plan
Optional Medical and dependent FSA
Work-visa sponsorship
Opportunity for advancement
Long-term assignment with opportunity for hire by client 
 
SELECT AWARDS
  • An INC 5000 company for 10 years
  • Corp! Michigan Economic Bright Spots 
  • Crain’s Detroit Business Top Staffing Service Companies in Detroit
  • TechServe Alliance Excellence Award- IT and Engineering Staffing & Solutions
  • Best of MichBusiness winner in HR Wizards & Partnerships
  • Metro Detroit Elite Category: Recruitment, Selection & Orientation for 101 Best & Brightest
  • 101 Best & Brightest Companies to Work for in Michigan
 
 

About the Company

K

KYYBA, Inc

Kyyba group of companies are privately held and specialize in staff augmentation, application software and project solutions. In operation for more than 15 years, we have earned an enviable track record and reputation within all the industries we serve. Our unique processes and maturity enables us to understand the needs of the business organizations and provide business solutions that match the real and compelling needs of our customers.

Headquartered in Michigan, Kyyba has multiple office locations and we serve local, regional and national client base consisting of Fortune 500 and middle market companies. Kyyba extends the above solutions and services to a broad spectrum of industry verticals ranging from automotive, insurance, technology, financial, transportation, government and so on.

COMPANY SIZE
100 to 499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1998
WEBSITE
http://www.kyyba.com/

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