Repligen
QA Associate I, Hardware/Systems
Repligen, Marlborough, Massachusetts, us, 01752
Overview
Repligen is an innovative life sciences company focused on developing and commercializing high-value bioprocessing products, technologies, and solutions critical in the production of biologic drugs.
We are currently seeking a QA Associate I to join our Quality team in Marlborough.
The successful candidate will be responsible for assisting the QA department to revise/create, file, organize, and review production documents. The candidate will work closely with the manufacturing team and document control department to ensure the changes are accurate and are made effective in a timely manner. This position involves completing the QA review of production records, including verification of raw materials used, verification of calculations, critical process steps, and evaluation of Factory Acceptance testing (FAT).
The QA Associate I will actively participate in the Repligen ISO 9001 Quality Management System and will be responsible for the review of system batch records and binder builds for Xcell ATF and Systems product lines and other TFF and TFDF systems.
Responsibilities
Responsibilities:Must be familiar with Factory Acceptance Test (FAT) for stainless steel cell culture systemsMust have knowledge of ASME BPE codes and requirementsMust be able to perform Quality Assurance on manufacturing of system product linesMust be able to build binders (Hardcopy/ eCopy) for Factory Acceptance Test (FAT)Must be familiar with GMP/ non-GMP systems used by pharmaceuticalsMust be able to work with Document Control for issuance of batch recordsMust have good communication skills to work with customersQualifications
Requirements:
At a minimum, a BA/BS degree (in a Biological Science, Engineering, or Physical Science preferred).Minimum 0-2 years' experience in Quality Assurance in an ISO 9001 certified Quality Management System or equivalentAbility to identify and ensure active and thorough investigations of quality issues identifying root causes and implementing corrective actions. Identifies and controls manufacturing process defects (scrap, nonconforming material, customer complaints) is highly preferred.What Repligen Offers
Excellent Benefits!
Health Insurance available on day one4 Competitive Medical Plan OptionsDental, Vision, Life and Disability Insurance Plans401KHealth Care Savings AccountWell Being Programs20 Days of PTOTuition Reimbursement Program
Repligen is an innovative life sciences company focused on developing and commercializing high-value bioprocessing products, technologies, and solutions critical in the production of biologic drugs.
We are currently seeking a QA Associate I to join our Quality team in Marlborough.
The successful candidate will be responsible for assisting the QA department to revise/create, file, organize, and review production documents. The candidate will work closely with the manufacturing team and document control department to ensure the changes are accurate and are made effective in a timely manner. This position involves completing the QA review of production records, including verification of raw materials used, verification of calculations, critical process steps, and evaluation of Factory Acceptance testing (FAT).
The QA Associate I will actively participate in the Repligen ISO 9001 Quality Management System and will be responsible for the review of system batch records and binder builds for Xcell ATF and Systems product lines and other TFF and TFDF systems.
Responsibilities
Responsibilities:Must be familiar with Factory Acceptance Test (FAT) for stainless steel cell culture systemsMust have knowledge of ASME BPE codes and requirementsMust be able to perform Quality Assurance on manufacturing of system product linesMust be able to build binders (Hardcopy/ eCopy) for Factory Acceptance Test (FAT)Must be familiar with GMP/ non-GMP systems used by pharmaceuticalsMust be able to work with Document Control for issuance of batch recordsMust have good communication skills to work with customersQualifications
Requirements:
At a minimum, a BA/BS degree (in a Biological Science, Engineering, or Physical Science preferred).Minimum 0-2 years' experience in Quality Assurance in an ISO 9001 certified Quality Management System or equivalentAbility to identify and ensure active and thorough investigations of quality issues identifying root causes and implementing corrective actions. Identifies and controls manufacturing process defects (scrap, nonconforming material, customer complaints) is highly preferred.What Repligen Offers
Excellent Benefits!
Health Insurance available on day one4 Competitive Medical Plan OptionsDental, Vision, Life and Disability Insurance Plans401KHealth Care Savings AccountWell Being Programs20 Days of PTOTuition Reimbursement Program