Senior Quality Regulatory Analyst - Clinical Laboratory

Are you an experienced Quality professional looking for a new challenge? Do you have an eye for details and a passion for quality? Labcorp is seeking a Senior Quality Analyst with high regulatory acumen for to join our team in Calabasas, CA.  In this role you will be responsible for supporting projects and activities as they relate to: quality management, quality assurance, quality training, continual improvement, safety, onboarding, and other responsibilities of the Quality Department.

The schedule for this position will be: Monday-Friday, 8am-5pm

Location: 4301 Lost Hills Rd, Calabasas Hills, CA 91301

Responsibilities:

• Review and approve batch records, in-process documents, analytical data and other regulatory documentation to ensure accuracy and compliance with GMP regulations.
• Assist operations group with investigating nonconforming events and complaints for root cause and corrective actions.
• Formulate responses to accreditation and regulatory citations.
• Monitor outcomes of root cause analysis, corrective actions and effectiveness checks.
• Maintains document control system, nonconformance and training records to assure consistency of applications and procedures.
• Maintains change control requests.
• Coordinates assembly of documents and submission packets to regulatory agencies.
• Supports the QA department during audits and inspections.
• Assists in establishing and reviewing validation protocols and reports.
• Prepares filing for necessary licensure, certification and/or accreditation as appropriate for the laboratory’s test complexity.
• Develops and maintains support systems related to risk management, including vendor evaluations.
• Keeps QA Manager informed of any significant issues affecting overall laboratory quality including but not limited to audit findings, validations, corrective and preventative actions.
• Works with department supervisors or management to assure new procedures are appropriately implemented and documented.
• Provide and ensure training for quality policies and procedures.
• Implements policies with respect to CLIA regulations, CAP accreditation, FDA compliance, and/or specific state regulations, providing organizational tools, e.g., forms, guidelines, consultation assistance.
• Adheres to the standard operating procedures and safety requirements of Esoterix, CLIA, CAP, OSHA and other regulatory bodies.
• Follows any other job-related instructions and performs any other job related duties requested by quality and department management.

Requirements:

• Bachelor’s Degree in a Life Science field of study or a related scientific field
• Minimum 3 years related experience in writing, monitoring and implementing quality programs for clinical, research laboratory or GxP regulated facilities
• Sound knowledge of cGMPs
• Demonstrated ability to interact with the operations group on quality issues.
• Experience hosting audits
• Working knowledge of quality assurance/quality management best practices
• Excellent analytical, critical thinking and problem solving skills
• Strong communication skills; both written and verbal
• High level of attention to detail with strong organizational skills
• Ability to work independently and within a team environment
• Strong computer skills with proficiency with MS Office programs
• Demonstrated ability to interact with the lab operations group on quality issues

Pay Range: $75,000-$110,000/year

Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Commissions, and Company bonus where applicable.  For more detailed information, please click here. 

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age,