Location
Type
Status
Open
West Greenwich, RI 02817
Full Job Description
HOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Specialist QA
Live
What you will do
Let’s do this! Let’s change the world! In this vital role, you will be responsible for PQA Off the Floor support and activities. This team is a centralized team supporting two manufacturing facilities (AR5 and AR30), as well as the entire Amgen Rhode Island site. The team provides coaching, mentorship, and guidance to Manufacturing, Quality Control, Process Development, Supply Chain, Facilities & Engineering and IS staff regarding quality systems processes and compliance. Responsibilities include the following: Provide Quality oversight to Major Deviations, Change Controls, CAPAs/EVs, New Product Introductions (NPIs), Product Re-Introductions (PRIs) and Master Batch Records (MBRs) to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
Additionally, this individual will be responsible for:
Ensuring that changes that could potentially impact product quality are assessed according to procedures
Ensuring that Facilities, Equipment, Materials, Manufacturing processes, Procedures and Products align with cGMP practices as well as other relevant regulations
Delivering Quality guidance to Document Management Systems records (CDOCs and GDMS)
Establishing and enable LEAN practices
Driving operational improvement initiatives and projects
Supporting Audits and Inspections
Full Job Description
HOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Specialist QA
Live
What you will do
Let’s do this! Let’s change the world! In this vital role, you will be responsible for PQA Off the Floor support and activities. This team is a centralized team supporting two manufacturing facilities (AR5 and AR30), as well as the entire Amgen Rhode Island site. The team provides coaching, mentorship, and guidance to Manufacturing, Quality Control, Process Development, Supply Chain, Facilities & Engineering and IS staff regarding quality systems processes and compliance. Responsibilities include the following: Provide Quality oversight to Major Deviations, Change Controls, CAPAs/EVs, New Product Introductions (NPIs), Product Re-Introductions (PRIs) and Master Batch Records (MBRs) to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
Additionally, this individual will be responsible for:
Ensuring that changes that could potentially impact product quality are assessed according to procedures
Ensuring that Facilities, Equipment, Materials, Manufacturing processes, Procedures and Products align with cGMP practices as well as other relevant regulations
Delivering Quality guidance to Document Management Systems records (CDOCs and GDMS)
Establishing and enable LEAN practices
Driving operational improvement initiatives and projects
Supporting Audits and Inspections
West Greenwich, RI 02817
Full Job Description
HOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Specialist QA
Live
What you will do
Let’s do this! Let’s change the world! In this vital role, you will be responsible for PQA Off the Floor support and activities. This team is a centralized team supporting two manufacturing facilities (AR5 and AR30), as well as the entire Amgen Rhode Island site. The team provides coaching, mentorship, and guidance to Manufacturing, Quality Control, Process Development, Supply Chain, Facilities & Engineering and IS staff regarding quality systems processes and compliance. Responsibilities include the following: Provide Quality oversight to Major Deviations, Change Controls, CAPAs/EVs, New Product Introductions (NPIs), Product Re-Introductions (PRIs) and Master Batch Records (MBRs) to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
Additionally, this individual will be responsible for:
Ensuring that changes that could potentially impact product quality are assessed according to procedures
Ensuring that Facilities, Equipment, Materials, Manufacturing processes, Procedures and Products align with cGMP practices as well as other relevant regulations
Delivering Quality guidance to Document Management Systems records (CDOCs and GDMS)
Establishing and enable LEAN practices
Driving operational improvement initiatives and projects
Supporting Audits and Inspections
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