14 days old

Specialist Quality Control

Amgen
Juncos, Puerto Rico 00777
  • Job Code
    115804261
Amgen

Job ID: R-87927
Location: Juncos, PR, US 00777

Come and grow with us

Are you looking for a meaningful new opportunity to test and growth your investigation skills? We have an immediate need for a Specialist Quality Control to join AML's Quality Control Facility. This is an outstanding opportunity to seek a variety of challenges and responsibilities in support to our manufacturing facility at Amgen Manufacturing Limited in Juncos, Puerto Rico.

The Role

The Specialist Quality Control role, functions as lead investigator and as the technical specialist for testing & development in areas of Biochemistry Molecular Biology and Microbiology. Focus on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources.

Specific responsibilities include but are not limited to:

  • Responsible for performing root cause analysis investigations and translating into actionable actions to prevent recurrences
  • Provide investigational reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise
  • Approve lab investigations
  • Responsible for providing technical mentorship
  • Provide reports, data analysis and ensure flow of communication between technical groups including following up and resolving issues that arise.
  • Resolve technical issues and troubleshoot for assays as necessary
  • Ensure lab compliance - which includes implementing procedures that improve GMP, GLP and safety.
  • Lead existing and/or develop and implement new programs, processes and methodologies
  • Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact.
  • Represent Quality Control in triage meetings to assess events identified by staff
  • Lead audit teams
  • May serve as subject matter expert to develop technical training.
  • May perform routine work in a specific area of responsibility as necessary
  • Represents the department/organization on various teams
  • Independently responsible for following through on multi-site action items.
  • May interact with regulatory agencies regarding area(s) of responsibility including written responses.
  • May problem tackle with outside resources.
  • Performs special projects as requested by supervisor
  • May supervise employees as necessary to meet technical requirements


For this opportunity the basic requirements are:

Doctorate degree in Life Sciences

Or

Master's degree in Life Sciences & 3 years of experience in Quality Control and/or GMP Laboratories.

Or

Bachelor's degree in Life Science & 5 years of experience in Quality Control and/or GMP Laboratories.

Beyond that, additional preferred qualifications are:

  • Educational background in Life Sciences
  • Understand, support and demonstrate the AMGEN values.
  • Excellent communication skills, facilitation and presentation skills.
  • Excellent technical writing skills in English.
  • Strong computer operation skills including word processing, presentation, database and spreadsheet application skills
  • Excellent project management and organizational skills including the ability to independently understand, follow, implement complex instructions and follow assignments through to completion.
  • Experience with Operational Excellence tools
  • Advanced skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities.
  • Excellent knowledge of and experience with processes involved in quality analytical labs, validation, manufacturing, quality assurance, process development and distribution.
  • Extensive knowledge of all testing including the development and validation of assays and the ability to perform all testing in specific area of responsibility.
  • Knowledge of pharmaceutical processes
  • Strong knowledge of U.S. regulations and practices pertaining to the testing of pharmaceutical/biological products.
  • Knowledge of basic international regulations and practices pertaining to the testing of pharmaceutical/biological products
  • Extensive knowledge and application of GMPs/CFRs.
  • Ability to evaluate compliance issues.
  • Skill in evaluating and documenting according to Company and various guidelines
  • Proficient at maintenance, troubleshooting and operation of equipment in area of expertise
  • Advanced scientific data analysis and interpretation skills
  • Advanced skills in solving complex problems
  • Advanced data trending and evaluation.
  • Strong skill in working independently and to effectively interact with various levels
  • Ability to interact with regulatory agencies both orally and in writing.
  • Initiate, coordinate and lead cross functional teams
  • Excellent skill in leading, motivating, influencing, and negotiating
  • Excellent communications skills in Spanish and English


The benefits

Our broad approach is one of the reasons why we are regularly recognized as a 'Best Place To Work'. We offer an outstanding benefits package that includes an award-winning retirement and stock plan. And between the paid time off, and wellness program - and on-site child care and fitness facilities - you will find us focused on your well-being too.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and demonstrates its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980.

Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.

PI115804261

<b>Amgen</b><br/><br/><b>Job ID: </b>R-87927<br/><b>Location: </b>Juncos, PR, US 00777<br/><br/><b>Come and grow with us</b><br><br>Are you looking for a meaningful new opportunity to test and growth your investigation skills? We have an immediate need for a Specialist Quality Control to join AML's Quality Control Facility. This is an outstanding opportunity to seek a variety of challenges and responsibilities in support to our manufacturing facility at Amgen Manufacturing Limited in Juncos, Puerto Rico.<br><br><b>The Role</b><br><br>The <b>Specialist Quality Control</b> role, functions as lead investigator and as the technical specialist for testing & development in areas of Biochemistry Molecular Biology and Microbiology. Focus on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources.<br><br><b><b>Specific responsibilities include but are not limited to:</b></b><br><br><ul><li>Responsible for performing root cause analysis investigations and translating into actionable actions to prevent recurrences</li><li>Provide investigational reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise</li><li>Approve lab investigations</li><li>Responsible for providing technical mentorship</li><li>Provide reports, data analysis and ensure flow of communication between technical groups including following up and resolving issues that arise.</li><li>Resolve technical issues and troubleshoot for assays as necessary</li><li>Ensure lab compliance - which includes implementing procedures that improve GMP, GLP and safety.</li><li>Lead existing and/or develop and implement new programs, processes and methodologies</li><li>Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact.</li><li>Represent Quality Control in triage meetings to assess events identified by staff</li><li>Lead audit teams</li><li>May serve as subject matter expert to develop technical training.</li><li>May perform routine work in a specific area of responsibility as necessary</li><li>Represents the department/organization on various teams</li><li>Independently responsible for following through on multi-site action items.</li><li>May interact with regulatory agencies regarding area(s) of responsibility including written responses.</li><li>May problem tackle with outside resources.</li><li>Performs special projects as requested by supervisor</li><li>May supervise employees as necessary to meet technical requirements</li></ul><br><br><b><b>For this opportunity the basic requirements are:</b></b><br><br>Doctorate degree in Life Sciences<br><br><b>Or</b><br><br>Master's degree in Life Sciences & 3 years of experience in Quality Control and/or GMP Laboratories.<br><br><b>Or</b><br><br>Bachelor's degree in Life Science & 5 years of experience in Quality Control and/or GMP Laboratories.<br><br><b><b>Beyond that, additional preferred qualifications are:</b></b><br><br><ul><li>Educational background in Life Sciences</li><li>Understand, support and demonstrate the AMGEN values.</li><li>Excellent communication skills, facilitation and presentation skills.</li><li>Excellent technical writing skills in English.</li><li>Strong computer operation skills including word processing, presentation, database and spreadsheet application skills</li><li>Excellent project management and organizational skills including the ability to independently understand, follow, implement complex instructions and follow assignments through to completion.</li><li>Experience with Operational Excellence tools</li><li>Advanced skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities.</li><li>Excellent knowledge of and experience with processes involved in quality analytical labs, validation, manufacturing, quality assurance, process development and distribution.</li><li>Extensive knowledge of all testing including the development and validation of assays and the ability to perform all testing in specific area of responsibility.</li><li>Knowledge of pharmaceutical processes</li><li>Strong knowledge of U.S. regulations and practices pertaining to the testing of pharmaceutical/biological products.</li><li>Knowledge of basic international regulations and practices pertaining to the testing of pharmaceutical/biological products</li><li>Extensive knowledge and application of GMPs/CFRs.</li><li>Ability to evaluate compliance issues.</li><li>Skill in evaluating and documenting according to Company and various guidelines</li><li>Proficient at maintenance, troubleshooting and operation of equipment in area of expertise</li><li>Advanced scientific data analysis and interpretation skills</li><li>Advanced skills in solving complex problems</li><li>Advanced data trending and evaluation.</li><li>Strong skill in working independently and to effectively interact with various levels</li><li>Ability to interact with regulatory agencies both orally and in writing.</li><li>Initiate, coordinate and lead cross functional teams</li><li>Excellent skill in leading, motivating, influencing, and negotiating</li><li>Excellent communications skills in Spanish and English</li></ul><br><br><b><b>The benefits</b></b><br><br>Our broad approach is one of the reasons why we are regularly recognized as a 'Best Place To Work'. We offer an outstanding benefits package that includes an award-winning retirement and stock plan. And between the paid time off, and wellness program - and on-site child care and fitness facilities - you will find us focused on your well-being too.<br><br>Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.<br><br>We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.<br><br>Amgen focuses on areas of high unmet medical need and demonstrates its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980.<br><br>Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.<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/E5dQOqSDPGqWsY5bsXman"> <p>PI115804261</p>

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Posted: 2019-11-25 Expires: 2019-12-26

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Specialist Quality Control

Amgen
Juncos, Puerto Rico 00777

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