Quality Control Manager - West Greenwich, RI at Amgen
Amgen · West Greenwich, United States Of America · Onsite
- Senior
- Office in West Greenwich
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
Let’s do this. Let’s change the world. In this vital role you will be responsible for on-site management of Quality Control Bioanalytics team (Monday - Friday).
Responsibilities include leading and supervision of staff, maintenance of the weekly lab schedule and prioritization of daily work tasks. Providing Quality oversight to ensure that processes are followed in accordance to current Good Manufacturing Practices (cGMP).
The Manager will ensure that facilities, equipment, materials, organization, processes, procedures and products align with cGMP practices and other applicable regulations. Perform review, approval and tracking of cGMP processes, procedures, documents and records, including but not limited to nonconformance records and CAPAs.
Additional Responsibilities:
Coordinates the scheduling and execution of testing including routine analysis and testing in support of technology transfer for product within the Bioanalytics Laboratories
Provides technical expertise/guidance to lab staff and within cross-functional Amgen teams
Leads the Bioanalytics Laboratory daily operations in relation to scheduling testing, project planning, management of materials, reagents, equipment, and laboratory staff
Reviews and approves controlled documents, including Standard Operating Procedures, Analytical Methods, Protocols and Reports related to Bioanalytics Lab activities
Ensures lab operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety and Laboratory Controls
Represents the Bioanalytics Lab during Amgen internal/external audits and inspections.
Direct interaction with regulatory agencies during on-site inspections
Provides oversight of Bioanalytics Lab Quality Systems records including, lab investigations, Deviations, CAPAs and Change Controls
Selects, develops, and evaluates laboratory staff to ensure functional objectives are met
Handles assignment and accuracy of staff training
Supports Continual Improvement and LEAN initiatives, programs and projects.
Ensures that changes that could potentially impact product quality are assessed according to procedures.
Ensures that deviations from established procedures are investigated and documented per procedures.
Ensures that records are complete, accurate, and documented according to written procedures and cGMP requirements.
Collaborates cross functionally as needed to ensure the Quality Management System processes are carried out in accordance with established procedures.
Alerts senior management of quality, compliance, supply and safety risks.
Supports internal/external audits and inspections as part of the audit/inspection management team.
Let’s do this. Let’s change the world. In this vital role you will be responsible for on-site management of Quality Control Bioanalytics team (Monday - Friday).
Responsibilities include leading and supervision of staff, maintenance of the weekly lab schedule and prioritization of daily work tasks. Providing Quality oversight to ensure that processes are followed in accordance to current Good Manufacturing Practices (cGMP).
The Manager will ensure that facilities, equipment, materials, organization, processes, procedures and products align with cGMP practices and other applicable regulations. Perform review, approval and tracking of cGMP processes, procedures, documents and records, including but not limited to nonconformance records and CAPAs.
Additional Responsibilities:
Coordinates the scheduling and execution of testing including routine analysis and testing in support of technology transfer for product within the Bioanalytics Laboratories
Provides technical expertise/guidance to lab staff and within cross-functional Amgen teams
Leads the Bioanalytics Laboratory daily operations in relation to scheduling testing, project planning, management of materials, reagents, equipment, and laboratory staff
Reviews and approves controlled documents, including Standard Operating Procedures, Analytical Methods, Protocols and Reports related to Bioanalytics Lab activities
Ensures lab operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety and Laboratory Controls
Represents the Bioanalytics Lab during Amgen internal/external audits and inspections.
Direct interaction with regulatory agencies during on-site inspections
Provides oversight of Bioanalytics Lab Quality Systems records including, lab investigations, Deviations, CAPAs and Change Controls
Selects, develops, and evaluates laboratory staff to ensure functional objectives are met
Handles assignment and accuracy of staff training
Supports Continual Improvement and LEAN initiatives, programs and projects.
Ensures that changes that could potentially impact product quality are assessed according to procedures.
Ensures that deviations from established procedures are investigated and documented per procedures.
Ensures that records are complete, accurate, and documented according to written procedures and cGMP requirements.
Collaborates cross functionally as needed to ensure the Quality Management System processes are carried out in accordance with established procedures.
Alerts senior management of quality, compliance, supply and safety risks.
Supports internal/external audits and inspections as part of the audit/inspection management team.
Job Category
Manufacturing
Minimum Education Required
High School/GED
City*
West Greenwich
Additional Qualifications/Responsibilities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a self starter with these qualifications.
Basic Qualifications:
High school diploma/GED and 12 years of Quality experience
Associate’s degree and 10 years of Quality experience OR
Bachelor’s degree and 5 years of Quality experience OR
Master’s degree and 3 years of Quality experience OR
Doctorate
In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
Preferred Qualifications:
Advanced degree in scientific field
Strong knowledge in HPLC/UPLC, Capillary Electrophoresis (CE SDS, cIEF, and/or cOligo), and/or general chemistry testing including UV, Osmolality, pH, polysorbate, subvisible particles, appearance, color and clarity
Familiarity with technology transfer process. Experience with validating analytical methods and ensuring that project deliverables meet established timelines
Strong level of analysis skills to evaluate and interpret data to arrive at logical and quality-minded conclusions. Experience applying problem-solving tools for root cause analysis
Leadership capabilities and experience applying GMP requirements in a Quality Control setting
Demonstrated ability to develop, coach and mentor employees
Excellent interpersonal, verbal, and written communication skills with all levels within the organization
Experience with successfully managing a team and delivering results in fast-paced and dynamic work environment
Ability to work in a team matrix environment and build relationships with partners.
Identify, lead, and champion innovative projects to advance efficiency and enable LEAN principles across different functions.
Establishment and review of department goals, strategies and KPIs.
Experience with various laboratory equipment and computer systems
Strong leadership and negotiation skills.
Innovative thinking and ability to transform work organizations
Exposure to Operational Excellence initiatives.
Ability to coordinate multi-functional project teams and deliver on schedule.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
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, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
117,706.00 USD - 139,820.00 USD
We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a self starter with these qualifications.
Basic Qualifications:
High school diploma/GED and 12 years of Quality experience
Associate’s degree and 10 years of Quality experience OR
Bachelor’s degree and 5 years of Quality experience OR
Master’s degree and 3 years of Quality experience OR
Doctorate
In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
Preferred Qualifications:
Advanced degree in scientific field
Strong knowledge in HPLC/UPLC, Capillary Electrophoresis (CE SDS, cIEF, and/or cOligo), and/or general chemistry testing including UV, Osmolality, pH, polysorbate, subvisible particles, appearance, color and clarity
Familiarity with technology transfer process. Experience with validating analytical methods and ensuring that project deliverables meet established timelines
Strong level of analysis skills to evaluate and interpret data to arrive at logical and quality-minded conclusions. Experience applying problem-solving tools for root cause analysis
Leadership capabilities and experience applying GMP requirements in a Quality Control setting
Demonstrated ability to develop, coach and mentor employees
Excellent interpersonal, verbal, and written communication skills with all levels within the organization
Experience with successfully managing a team and delivering results in fast-paced and dynamic work environment
Ability to work in a team matrix environment and build relationships with partners.
Identify, lead, and champion innovative projects to advance efficiency and enable LEAN principles across different functions.
Establishment and review of department goals, strategies and KPIs.
Experience with various laboratory equipment and computer systems
Strong leadership and negotiation skills.
Innovative thinking and ability to transform work organizations
Exposure to Operational Excellence initiatives.
Ability to coordinate multi-functional project teams and deliver on schedule.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
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, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
117,706.00 USD - 139,820.00 USD
State*
Rhode Island
Salary Range
>$100,000
