29 days old

Manufacturing Specialist - Quality Systems Record Owner

Amgen
Thousand Oaks, CA 91360
  • Job Code
    115544789
Amgen

Job ID: R-83119_1
Location: Thousand Oaks, CA, US 91360

This Specialist Manufacturing position will support the drug substance manufacturing operations in Thousand Oaks, CA. This role requires an experienced and well qualified individual to focus primarily on Quality Systems record ownership (Change Control, deviation, CAPA), in addition to managing projects. This individual will play a key role in managing multiple Change Records with varying complexity. Also the staff member will be leading the investigation of nonconforming events related to the manufacturing operations. The candidate will lead root cause analysis, definition of event scope and lot-tying strategy, assessment of product impact and development and coordination of corrective actions to prevent recurrence. The role may also require management of document revisions, as necessary.

Under general direction, assume primary responsibility for execution of the Change Control/deviation/CAPA process in manufacturing. The job will also require trending of nonconforming events to identify systemic issues that need improvement, and tracking and reporting key quality systems metrics to management. Apply process, operational, scientific expertise, compliance knowledge, analytical and troubleshooting skills to support manufacturing operations. Candidates should have good project management skills.

Job Scope and responsibilities:
  • Assume ownership of critical Change Record, and nonconforming event investigations within Amgen's Quality Management System (Change Control/ Deviation /CAPA) using the Trackwise database.
  • Represent the manufacturing support team internally within the plant and externally at the site level.
  • Serve as department subject matter expert for the Change Control/ deviation/CAPA process, including metrics reporting and trending.
  • Prepare, coordinate, and present complex information at cross-functional team meetings, teleconferences, various governance meetings, and management review.
  • Ensure good progress, participation, communication and timely outcomes through cross functional team members who support MFG
  • Apply scientific reasoning and troubleshooting techniques to solve complex process, compliance, and analytical problems in order to ensure MFG production success. This may include support of any of the following; process improvements, operational excellence initiatives, project management, and new product introductions
  • Will work with other functions (Quality, Engineering, Automation, Facilities, Environmental Health & Safety, Process Development, etc.) in troubleshooting nonconforming events, conducting problem solving and RCAs, owning major deviations, complex change records, and developing CAPAs to prevent recurrence.
  • Collaborate with Regulatory and Quality partners to manage records and respond to regulatory questions and/or audit findings.

Basic Qualifications:

Doctorate degree

OR

Master's degree & 3 years of manufacturing and operations experience

OR

Bachelor's degree & 5 years of manufacturing and operations experience

OR

Associate's degree & 10 years of manufacturing and operations experience

OR

High school diploma / GED & 12 years of manufacturing and operations experience

Preferred Qualifications:

Advanced Degree in Engineering or Life Sciences

Experience in GMP Technical Support roles, GMP operations, Engineering, or Process Development.

Technical knowledge of drug substance processing and broad understanding of related disciplinary areas

Demonstrated project management abilities

Experience in contamination investigations, recovery, and prevention including aseptic technique and clean room behavior.

Ability to organize, analyze, and interprets technical data through trend analysis.

Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms

Significant experience with Quality Systems Record ownership

Ability to drive results through leadership of cross-functional teams.

Join Us
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

PI115544789

<b>Amgen</b><br/><br/><b>Job ID: </b>R-83119_1<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>This Specialist Manufacturing position will support the drug substance manufacturing operations in Thousand Oaks, CA. This role requires an experienced and well qualified individual to focus primarily on Quality Systems record ownership (Change Control, deviation, CAPA), in addition to managing projects. This individual will play a key role in managing multiple Change Records with varying complexity. Also the staff member will be leading the investigation of nonconforming events related to the manufacturing operations. The candidate will lead root cause analysis, definition of event scope and lot-tying strategy, assessment of product impact and development and coordination of corrective actions to prevent recurrence. The role may also require management of document revisions, as necessary.<br><br>Under general direction, assume primary responsibility for execution of the Change Control/deviation/CAPA process in manufacturing. The job will also require trending of nonconforming events to identify systemic issues that need improvement, and tracking and reporting key quality systems metrics to management. Apply process, operational, scientific expertise, compliance knowledge, analytical and troubleshooting skills to support manufacturing operations. Candidates should have good project management skills.<br><br><strong>Job Scope and responsibilities:</strong><br><ul><li>Assume ownership of critical Change Record, and nonconforming event investigations within Amgen's Quality Management System (Change Control/ Deviation /CAPA) using the Trackwise database.</li><li>Represent the manufacturing support team internally within the plant and externally at the site level. </li><li>Serve as department subject matter expert for the Change Control/ deviation/CAPA process, including metrics reporting and trending.</li><li>Prepare, coordinate, and present complex information at cross-functional team meetings, teleconferences, various governance meetings, and management review.</li><li>Ensure good progress, participation, communication and timely outcomes through cross functional team members who support MFG</li><li>Apply scientific reasoning and troubleshooting techniques to solve complex process, compliance, and analytical problems in order to ensure MFG production success. This may include support of any of the following; process improvements, operational excellence initiatives, project management, and new product introductions</li><li>Will work with other functions (Quality, Engineering, Automation, Facilities, Environmental Health & Safety, Process Development, etc.) in troubleshooting nonconforming events, conducting problem solving and RCAs, owning major deviations, complex change records, and developing CAPAs to prevent recurrence.</li><li>Collaborate with Regulatory and Quality partners to manage records and respond to regulatory questions and/or audit findings.</li></ul><br><strong>Basic Qualifications:</strong><br><br>Doctorate degree<br><br>OR<br><br>Master's degree & 3 years of manufacturing and operations experience<br><br>OR<br><br>Bachelor's degree & 5 years of manufacturing and operations experience<br><br>OR<br><br>Associate's degree & 10 years of manufacturing and operations experience<br><br>OR<br><br>High school diploma / GED & 12 years of manufacturing and operations experience<br><br><strong>Preferred Qualifications:</strong><br><br>Advanced Degree in Engineering or Life Sciences<br><br>Experience in GMP Technical Support roles, GMP operations, Engineering, or Process Development.<br><br>Technical knowledge of drug substance processing and broad understanding of related disciplinary areas<br><br>Demonstrated project management abilities<br><br>Experience in contamination investigations, recovery, and prevention including aseptic technique and clean room behavior.<br><br>Ability to organize, analyze, and interprets technical data through trend analysis.<br><br>Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms<br><br>Significant experience with Quality Systems Record ownership<br><br>Ability to drive results through leadership of cross-functional teams.<br><br><strong>Join Us</strong><br>If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.<br><br>Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.<br><br>As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.<br><br>Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.<br><br>Join Us <br> <br> If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. <br> <br> Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. <br> <br> As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. <br> <br> Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.<br/><br/> <img src="https://analytics.click2apply.net/v/g2oq6LS7roOVSxaAIlr4k"> <p>PI115544789</p>

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Posted: 2019-11-16 Expires: 2019-12-17

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Manufacturing Specialist - Quality Systems Record Owner

Amgen
Thousand Oaks, CA 91360

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