TalentBurst
3 days ago Be among the first 25 applicants
TalentBurst, an Inc 5000 company provided pay range
This range is provided by TalentBurst, an Inc 5000 company. Your actual pay will be based on your skills and experience talk with your recruiter to learn more. Base pay range
$30.00/hr - $40.00/hr Duration: 12+ Months Contract Schedule: Alternate Saturday, Sunday Tuesday, 06:00 PM 07:00 AM
Job Description: Education and Experience:
B.S. in scientific discipline or equivalent work experience. Prior batch record execution or review experience. Prior experience in investigation, change control, and other Quality Management Systems (QMS). Working knowledge of cGMPs. Excellent written and verbal communication and interpersonal skills. Strong analytical and problem-solving skills. Manufacturing and Manufacturing Sciences experience preferred.
Key Responsibilities:
Provide on-the-floor QA oversight and support to manufacturing operations. Review executed batch records and associated documents to ensure compliance with approved procedures and cGMP expectations. Respond to quality-related incidents or non-conformances on the floor and secure necessary documentation for real-time investigations. Represent QA in support of deviations including active participation in Root Cause Analysis (RCA). Provide cGMP and compliance guidance to Manufacturing and Novato Technical Services (NTS) personnel. Provide QA support including authoring, review, and approval of documents in Quality Management Systems in accordance with BioMarin policies. Perform area walkthroughs. Perform other duties and projects as assigned by management.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Science, Research, and Engineering
Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
Referrals increase your chances of interviewing at TalentBurst, an Inc 5000 company by 2x. #J-18808-Ljbffr
This range is provided by TalentBurst, an Inc 5000 company. Your actual pay will be based on your skills and experience talk with your recruiter to learn more. Base pay range
$30.00/hr - $40.00/hr Duration: 12+ Months Contract Schedule: Alternate Saturday, Sunday Tuesday, 06:00 PM 07:00 AM
Job Description: Education and Experience:
B.S. in scientific discipline or equivalent work experience. Prior batch record execution or review experience. Prior experience in investigation, change control, and other Quality Management Systems (QMS). Working knowledge of cGMPs. Excellent written and verbal communication and interpersonal skills. Strong analytical and problem-solving skills. Manufacturing and Manufacturing Sciences experience preferred.
Key Responsibilities:
Provide on-the-floor QA oversight and support to manufacturing operations. Review executed batch records and associated documents to ensure compliance with approved procedures and cGMP expectations. Respond to quality-related incidents or non-conformances on the floor and secure necessary documentation for real-time investigations. Represent QA in support of deviations including active participation in Root Cause Analysis (RCA). Provide cGMP and compliance guidance to Manufacturing and Novato Technical Services (NTS) personnel. Provide QA support including authoring, review, and approval of documents in Quality Management Systems in accordance with BioMarin policies. Perform area walkthroughs. Perform other duties and projects as assigned by management.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Science, Research, and Engineering
Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
Referrals increase your chances of interviewing at TalentBurst, an Inc 5000 company by 2x. #J-18808-Ljbffr