Job details
Salary $45 - $55 an hour job type full-time contract number of hires for this role 3
Qualifications
Iso 9001: 1 year (preferred)
Us work authorization (preferred)
Full job description
Responsibilities
Ensures capa system is fully implemented and integrated with other elements of quality management system.
Promotes recognition of quality program among it and business colleagues and collaborators.
Coordinates, reviews, tracks, and reports on the nonconformance, capas, and deviations that are generated as part of the capa quality system.
Prepares and approves documentation per policy and procedure to support the capa quality system.
Responsible for designing and maintaining programs for the systematic monitoring and evaluation of the various aspects of a project, or service to ensure that standards of quality are being met.
Evaluates and provides guidance on the methods and procedures to input quality events into the capa system.
Assists with analysis of quality data to identify problems or unfavorable trends that may require corrective or preventive actions.
Provides independent review of investigations associated with nonconformances and capa, deviations, and change control activities.
Challenges the quality data information systemEnsures that the data received by the capa system are complete, accurate and timely.
Oversees and monitors the open nonconformance’s to ensure all activities are being completed in a timely manner.
Identifies recurring events and ensures appropriate actions are taken as necessary and any trends are escalated for review.
Leads/facilitates continuous improvement initiatives based on feedback, process monitoring results, etc.
Provides guidance on the capa system, event descriptions, investigations, root cause analysis, and resolution plans.
Updates and reviews standard operating procedures, work instructions, forms document id: btsqc02.01.jd103 version 2, effective and templates in support the capa program.
Assists as needed in audits and inspections.
Supports gxp inspections and audits from both internal and external regulatory authorities and collaborators and supports drafting of follow-up responses for all aspects of the business.
Assists on special projects and performs other activities associated with tracking of capas, deviations and other exception records.
Requirements
Proficient in understanding of gxp regulations.
Bachelor’s degree in science, engineering, computer systems or related disciplines required; masters preferred
At least 5 years of experience in the life science sector (medical device, pharmaceutical, biotech)
Strong analytical skills with the ability to organize work in a logical, thorough and succinct manner.
Highly self-motivated, self-directed.
Understanding of risk management principles, regulatory requirements and, industry best practices.
Flexibility to adapt to changing priorities.
Effective with written and verbal in english communications at all levels, providing input and regulatory guidance to project teams.
Role must maintain compliance expertise and be effective at applying requirements in the it and business environment that supports business goals and maintaining a compliant state.
Contact the job poster
Seth staerkel 2nd
Senior corporate recruiter at pqe group
Send inmail
Job types: full-time, contract
Pay: $45.00 - $55.00 per hour
Schedule:
8 hour shift
Experience:
Iso 9001: 1 year (preferred)
Work location:
Multiple locations
Work location: multiple locations
