Maravai and Kirkland & Ellis LLP
Temporary Sr. Quality Assurance Associate
Maravai and Kirkland & Ellis LLP, San Diego, California, United States, 92189
Your next role as a Miracle Maker
TriLink BioTechnologies is seeking a #MiracleMaker to join our Quality Assurance team as a Temporary Senior Quality Assurance Associate. As a Temporary Senior Quality Assurance Associate, you will support the Quality Operations function, including the review and release of GMP batch records, review and approval of deviations, NCMRs, CAPAs, OOSs, and complaints. In this role, you will ensure compliance with company policies and procedures and applicable domestic and international standards and regulations.
How you will make an impact:
Responsible for reviewing and approving GMP batch records and associated documentation required for GMP final product release.
Responsible for initiating and reviewing Quality Events (e.g. Deviations, NCMRs, CAPA and OOSs) to ensure appropriate investigations are completed in a timely manner.
Assist in conducting quality investigations to assess root cause, corrections, corrective actions, preventive actions, and monitor effectiveness. Use of quality tools, such as 5-Why's, FMEA's, Cause and Effect Diagrams, Process Mapping, etc.
Assure compliance with all in-house or external specifications to standards, such as ISO and GMP regulations.
Work with various functions, including Manufacturing, QC, R&D, commercial, customer service, technical support, facilities, IT, etc. to continuously improve the Quality Management System.
Assist in internal and external audits, as necessary.
Support and follow up on client requests.
Perform other functions and duties as required.
The skills and experience that you will bring:
Minimum, Bachelor's Degree in scientific discipline (Chemistry, Biology, Bioengineering, etc.) or equivalent experience.
Quality professional with a minimum of 3-5 years relevant experience in a life science industry.
Requires knowledge of ISO 9001 standards (or ISO 13485) and cGMPs regulations (e.g. ICH Q7 Practice Guidance for Active Pharmaceutical Ingredients, or 21 CFR 210, 211 or 21 CFR 820).
Strong and effective verbal and written communication skills.
Strong interpersonal, teamwork and customer interfacing skills.
Strong problem-solving skills and analytical skills applied to investigations.
Self-motivated and able to organize and prioritize multiple tasks.
Ability to identify quality issues/discrepancies and effectively resolve discrepancies within the organization.
The anticipated salary range for this position is $38.45 - $40.80 per hour. The salary offer will depend on multiple factors which may include the successful candidate's skills, experience, and other qualifications, as well as the location of the role.
#J-18808-Ljbffr
TriLink BioTechnologies is seeking a #MiracleMaker to join our Quality Assurance team as a Temporary Senior Quality Assurance Associate. As a Temporary Senior Quality Assurance Associate, you will support the Quality Operations function, including the review and release of GMP batch records, review and approval of deviations, NCMRs, CAPAs, OOSs, and complaints. In this role, you will ensure compliance with company policies and procedures and applicable domestic and international standards and regulations.
How you will make an impact:
Responsible for reviewing and approving GMP batch records and associated documentation required for GMP final product release.
Responsible for initiating and reviewing Quality Events (e.g. Deviations, NCMRs, CAPA and OOSs) to ensure appropriate investigations are completed in a timely manner.
Assist in conducting quality investigations to assess root cause, corrections, corrective actions, preventive actions, and monitor effectiveness. Use of quality tools, such as 5-Why's, FMEA's, Cause and Effect Diagrams, Process Mapping, etc.
Assure compliance with all in-house or external specifications to standards, such as ISO and GMP regulations.
Work with various functions, including Manufacturing, QC, R&D, commercial, customer service, technical support, facilities, IT, etc. to continuously improve the Quality Management System.
Assist in internal and external audits, as necessary.
Support and follow up on client requests.
Perform other functions and duties as required.
The skills and experience that you will bring:
Minimum, Bachelor's Degree in scientific discipline (Chemistry, Biology, Bioengineering, etc.) or equivalent experience.
Quality professional with a minimum of 3-5 years relevant experience in a life science industry.
Requires knowledge of ISO 9001 standards (or ISO 13485) and cGMPs regulations (e.g. ICH Q7 Practice Guidance for Active Pharmaceutical Ingredients, or 21 CFR 210, 211 or 21 CFR 820).
Strong and effective verbal and written communication skills.
Strong interpersonal, teamwork and customer interfacing skills.
Strong problem-solving skills and analytical skills applied to investigations.
Self-motivated and able to organize and prioritize multiple tasks.
Ability to identify quality issues/discrepancies and effectively resolve discrepancies within the organization.
The anticipated salary range for this position is $38.45 - $40.80 per hour. The salary offer will depend on multiple factors which may include the successful candidate's skills, experience, and other qualifications, as well as the location of the role.
#J-18808-Ljbffr