Blackwomenintech
Specialist, Laboratory Quality Assurance
Blackwomenintech, Rahway, New Jersey, us, 07065
Job DescriptionOur Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed in alignment with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers, and suppliers, we create an interdependent global manufacturing network
dedicated
to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.The Laboratory Specialist within the Quality Assurance Center of Excellence, with guidance from the Associate Director of Quality Assurance, provides Quality support to Laboratory Operations. The Laboratory Specialist will review laboratory data to ensure that all laboratory data is maintained in accordance with prescribed specifications, procedures, and Good Documentation Practices. Data review will include the evaluation of raw data as well as verification of final data integrity (i.e., calculations, adherence to SOPs, BATs, BLPs, Compendia). The Laboratory Specialist will also approve Master Laboratory worksheets prior to issuance to Laboratory Operations.The Laboratory Specialist will represent quality on the shop floor and perform documentation accuracy and completeness checks while on the shop floor. He or she will work closely with the assigned laboratory in a team environment to ensure timely reviews of documentation and to ensure that documentation is completed right the first time. The Laboratory Specialist will work with Laboratory Operations staff and management to remediate comments and errors in documentation. He or she may also assist Laboratory Operations in conducting investigations associated with laboratory data review. Additionally, the Laboratory Specialist will utilize time on the shop floor to provide Quality coaching and guidance to Laboratory Operations and technology personnel, to enable right first time testing and to ensure compliance with cGMPs and regulatory requirements.The Laboratory Specialist will also be trained to support Quality Assurance system functions and to support End to End Quality Operations as needed.Primary Activities:Present on shop floor to provide compliance support and to provide Quality coaching and guidance to Laboratory Operations and Technology personnel.Actively participate in the Tier process and use this forum to make concerns visible and to partner with Laboratory Operations on resolution.Responsible for the independent auditing of laboratory data in alignment with the policies of the department, division, company, and other applicable mandates. Maintain the highest level of proficiency in terms of those duties and responsibilities required of auditors.Maintain metrics and tracking associated with these documentation reviews.Complete the remediation activities for all data reviews, to ensure errors are appropriately corrected and documented following departmental and site procedures.Perform review and approval of qualification documents as needed.Ensure that laboratory data is in compliance with cGMPs, GLPs, and departmental procedures and assay methods and is of the highest integrity, quality, and accuracy.Responsible for approval of Master Laboratory Worksheets prior to issuance to floor for use.Responsible for issuance of new and reconciliation of completed laboratory worksheets.Foster a customer service attitude within Laboratory Operations.Review laboratory notebooks, logbooks, and CTU records to ensure accuracy and data integrity compliance.Assist with training of incoming personnel.Provide support to Regulatory Agency inspections as needed.Education RequirementsBachelor's degree. Degree in life science, scientific discipline, or engineering preferred OR M.S. degree in life science, scientific discipline, or engineering.
In lieu of a Life Sciences or other Bachelor's degree, equivalent direct experience of 6 years of working in a GMP environment, direct experience with documentation review and/or control, or prior experience supporting Regulatory Agency inspections is required.
Experience and SkillsRequiredMinimum 1-2 years experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical, or Regulatory function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science-related, or regulated setting.
Leadership skills connected with strategic and effective verbal and written communication skills.
Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.
Demonstrated interpersonal skills including flexibility, collaboration, and inclusion skills and ability to work in a team environment.
Titers may be required.
PreferredDemonstrated analytical aptitude, critical thinking skills, and problem-solving skills.
Demonstrated ability to upskill/coach others.
Strong written and verbal communication skills.
Experience in pharmaceutical laboratory operations or related environment.
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dedicated
to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.The Laboratory Specialist within the Quality Assurance Center of Excellence, with guidance from the Associate Director of Quality Assurance, provides Quality support to Laboratory Operations. The Laboratory Specialist will review laboratory data to ensure that all laboratory data is maintained in accordance with prescribed specifications, procedures, and Good Documentation Practices. Data review will include the evaluation of raw data as well as verification of final data integrity (i.e., calculations, adherence to SOPs, BATs, BLPs, Compendia). The Laboratory Specialist will also approve Master Laboratory worksheets prior to issuance to Laboratory Operations.The Laboratory Specialist will represent quality on the shop floor and perform documentation accuracy and completeness checks while on the shop floor. He or she will work closely with the assigned laboratory in a team environment to ensure timely reviews of documentation and to ensure that documentation is completed right the first time. The Laboratory Specialist will work with Laboratory Operations staff and management to remediate comments and errors in documentation. He or she may also assist Laboratory Operations in conducting investigations associated with laboratory data review. Additionally, the Laboratory Specialist will utilize time on the shop floor to provide Quality coaching and guidance to Laboratory Operations and technology personnel, to enable right first time testing and to ensure compliance with cGMPs and regulatory requirements.The Laboratory Specialist will also be trained to support Quality Assurance system functions and to support End to End Quality Operations as needed.Primary Activities:Present on shop floor to provide compliance support and to provide Quality coaching and guidance to Laboratory Operations and Technology personnel.Actively participate in the Tier process and use this forum to make concerns visible and to partner with Laboratory Operations on resolution.Responsible for the independent auditing of laboratory data in alignment with the policies of the department, division, company, and other applicable mandates. Maintain the highest level of proficiency in terms of those duties and responsibilities required of auditors.Maintain metrics and tracking associated with these documentation reviews.Complete the remediation activities for all data reviews, to ensure errors are appropriately corrected and documented following departmental and site procedures.Perform review and approval of qualification documents as needed.Ensure that laboratory data is in compliance with cGMPs, GLPs, and departmental procedures and assay methods and is of the highest integrity, quality, and accuracy.Responsible for approval of Master Laboratory Worksheets prior to issuance to floor for use.Responsible for issuance of new and reconciliation of completed laboratory worksheets.Foster a customer service attitude within Laboratory Operations.Review laboratory notebooks, logbooks, and CTU records to ensure accuracy and data integrity compliance.Assist with training of incoming personnel.Provide support to Regulatory Agency inspections as needed.Education RequirementsBachelor's degree. Degree in life science, scientific discipline, or engineering preferred OR M.S. degree in life science, scientific discipline, or engineering.
In lieu of a Life Sciences or other Bachelor's degree, equivalent direct experience of 6 years of working in a GMP environment, direct experience with documentation review and/or control, or prior experience supporting Regulatory Agency inspections is required.
Experience and SkillsRequiredMinimum 1-2 years experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical, or Regulatory function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science-related, or regulated setting.
Leadership skills connected with strategic and effective verbal and written communication skills.
Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.
Demonstrated interpersonal skills including flexibility, collaboration, and inclusion skills and ability to work in a team environment.
Titers may be required.
PreferredDemonstrated analytical aptitude, critical thinking skills, and problem-solving skills.
Demonstrated ability to upskill/coach others.
Strong written and verbal communication skills.
Experience in pharmaceutical laboratory operations or related environment.
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