Quality Assurance Specialist Vaccine Business Division (Bozeman Montana)
Company Name:
Takeda Pharmaceuticals
OBJECTIVES:
Effectively manage Contract Manufacturing and Quality Control testing laboratories in support of GMP manufacturing.This objective includes method and process transfer, validation, manufacturing, testing, release and distribution of vaccine products.
Provide QA guidance and support to R&D CMC groups within Takeda Vaccines Inc.
Ensure GMP compliance for all manufacturing and testing related to products for Takeda Vaccines Inc.
ACCOUNTABILITIES:
Review and approve batch records, prepare annual product reviews, process technical complaints.
Review and approve documentation for tech transfer and validation of analytical methods and manufacturing processes.
Conduct investigations into Good Manufacturing Practice (GMP) related issues or problems associated with audits, batch records, and complaints.Assist with management of manufacturing and testing deviations, out-of-specification results, and investigations.
Prepare Chemistry, Manufacturing, and Controls (CMC)
information for regulatory submissions and annual reports.Participate in the resolution of problems/concerns.
In conjunction with contractors and/or internal manufacturing groups, develop and oversee packaging and labeling for Chemical Trial Materials (CTM).Arrange for testing of CTM and review data for acceptance.
Conduct audits at contract manufacturing, testing, packaging, and warehouse/distribution operations to assure adherence to regulatory requirements.Issue audit reports and follow up on corrective actions.
Conduct internal audits at Takeda Vaccines for GMP compliance.
Maintain QA records according to applicable regulatory requirements and Takeda policy.Draft and review internal GMP documents such as standard operating procedures, certificates of analysis, and specifications.Review and approve release and stability test results and manage associated QA tracking and trending information to QA management.
Manage a scheduled, documented training program in appropriate areas of regulatory compliance.
Other duties as assigned.Qualifications
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
Bachelor's Degree or higher in a scientific discipline.
Minimum of 2 years experience in quality or regulatory compliance within the pharmaceuticals, biologics, or other related industry(ies).
Good Manufacturing Practice auditing and training experience.
Experience with equipment, analytical method and process validation is a plus.
Excellent communication skills both oral and written.
Must be able to work productively as a member of multi functional and diverse teams.
PHYSICAL DEMANDS:
Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
Lifting and moving supplies and equipment (up to 25 pounds).
TRAVEL REQUIREMENTS:
Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
Requires approximately 25% travel.
We are driven to improve people''s lives.
Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information,
No Phone Calls or Recruiters Please.
LI-KB1
Schedule
RegularFull-timeEstimated Salary: $20 to $28 per hour based on qualifications.
Takeda Pharmaceuticals
OBJECTIVES:
Effectively manage Contract Manufacturing and Quality Control testing laboratories in support of GMP manufacturing.This objective includes method and process transfer, validation, manufacturing, testing, release and distribution of vaccine products.
Provide QA guidance and support to R&D CMC groups within Takeda Vaccines Inc.
Ensure GMP compliance for all manufacturing and testing related to products for Takeda Vaccines Inc.
ACCOUNTABILITIES:
Review and approve batch records, prepare annual product reviews, process technical complaints.
Review and approve documentation for tech transfer and validation of analytical methods and manufacturing processes.
Conduct investigations into Good Manufacturing Practice (GMP) related issues or problems associated with audits, batch records, and complaints.Assist with management of manufacturing and testing deviations, out-of-specification results, and investigations.
Prepare Chemistry, Manufacturing, and Controls (CMC)
information for regulatory submissions and annual reports.Participate in the resolution of problems/concerns.
In conjunction with contractors and/or internal manufacturing groups, develop and oversee packaging and labeling for Chemical Trial Materials (CTM).Arrange for testing of CTM and review data for acceptance.
Conduct audits at contract manufacturing, testing, packaging, and warehouse/distribution operations to assure adherence to regulatory requirements.Issue audit reports and follow up on corrective actions.
Conduct internal audits at Takeda Vaccines for GMP compliance.
Maintain QA records according to applicable regulatory requirements and Takeda policy.Draft and review internal GMP documents such as standard operating procedures, certificates of analysis, and specifications.Review and approve release and stability test results and manage associated QA tracking and trending information to QA management.
Manage a scheduled, documented training program in appropriate areas of regulatory compliance.
Other duties as assigned.Qualifications
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
Bachelor's Degree or higher in a scientific discipline.
Minimum of 2 years experience in quality or regulatory compliance within the pharmaceuticals, biologics, or other related industry(ies).
Good Manufacturing Practice auditing and training experience.
Experience with equipment, analytical method and process validation is a plus.
Excellent communication skills both oral and written.
Must be able to work productively as a member of multi functional and diverse teams.
PHYSICAL DEMANDS:
Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
Lifting and moving supplies and equipment (up to 25 pounds).
TRAVEL REQUIREMENTS:
Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
Requires approximately 25% travel.
We are driven to improve people''s lives.
Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information,
No Phone Calls or Recruiters Please.
LI-KB1
Schedule
RegularFull-timeEstimated Salary: $20 to $28 per hour based on qualifications.
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