What are the responsibilities and job description for the Manager Quality Control I - Nights position at BioSpace?
Join Amgens Mission of Serving Patients
At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
MANAGER QUALITY CONTROL I NIGHT SHIFT
NOTE: This is a Wednesday - Saturday schedule night shift.
What you will do
Lets do this. Lets change the world. In this vital role you will play a key role in the Quality Control teamas the Manager for night shift support. Reporting directly to the Director of Quality Control, the Manager, Quality Control I (Night Shift) is an experienced QC professional who provides independent technical execution and shift-level leadership within a GMP-regulated laboratory environment. This role is accountable for leading night shift QC operations, ensuring accurate sample management, timely analytical testing, and sustained compliance with GMP, data integrity, and safety requirements.
Provide operational leadership for QC night shift activities, including sample receipt, prioritization, and accurate entry into LIMS.
Serve as the primary QC point of contact for Manufacturing during night shift operations, supporting production schedules, issue resolution, and risk escalation.
Independently perform routine and complex analytical testing in chemistry, bioassay, and/or microbiology, including STAT testing as required.
Ensure accurate, compliant documentation in accordance with GDP, GMP, and 21 CFR Part 11 requirements.
Support laboratory investigations related to deviations or OOS results and communicate shift-level risks to QC leadership.
Utilize electronic systems including LIMS, Biovia (LES, ELN, CIMS/CISPro), and Veeva Vault (QualityDocs, QMS).
Collaborate cross-functionally to meet testing timelines and contribute to continuous improvement initiatives.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications.
Basic Qualifications
High school diploma / GED and 12 years of quality control experience OR
Associates degree and 10 years of quality control experience OR
Bachelors degree and 5 years of quality control experience OR
Masters degree and 3 years of quality control experience OR
Doctorate degree
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
Bachelors degree in a scientific discipline or equivalent experience.
Experience working in a GMP-regulated Quality Control laboratory with demonstrated ability to work independently.
Prior experience serving as a shift lead, point of contact, or informal team lead within a QC laboratory.
Hands-on analytical testing experience in chemistry, bioassay, and/or microbiology.
Strong knowledge of data integrity, GDP, GMP, and 21 CFR Part 11 compliance.
Familiarity with compendial methods (e.g., USPNF).
Excellent communication and organizational skills with the ability to manage multiple priorities in a fast-paced manufacturing environment.
High attention to detail, strong problem-solving skills, and ability to work autonomously during off-shift hours.
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, well support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In Addition To The Base Salary, Amgen Offers a Total Rewards Plan, Based On Eligibility, Comprising Of Health And Welfare Plans For Staff And Eligible Dependents, Financial Plans With Opportunities To Save Towards Retirement Or Other Goals, Work/life Balance, And Career Development Opportunities That May Include
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
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.
At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
MANAGER QUALITY CONTROL I NIGHT SHIFT
NOTE: This is a Wednesday - Saturday schedule night shift.
What you will do
Lets do this. Lets change the world. In this vital role you will play a key role in the Quality Control teamas the Manager for night shift support. Reporting directly to the Director of Quality Control, the Manager, Quality Control I (Night Shift) is an experienced QC professional who provides independent technical execution and shift-level leadership within a GMP-regulated laboratory environment. This role is accountable for leading night shift QC operations, ensuring accurate sample management, timely analytical testing, and sustained compliance with GMP, data integrity, and safety requirements.
Provide operational leadership for QC night shift activities, including sample receipt, prioritization, and accurate entry into LIMS.
Serve as the primary QC point of contact for Manufacturing during night shift operations, supporting production schedules, issue resolution, and risk escalation.
Independently perform routine and complex analytical testing in chemistry, bioassay, and/or microbiology, including STAT testing as required.
Ensure accurate, compliant documentation in accordance with GDP, GMP, and 21 CFR Part 11 requirements.
Support laboratory investigations related to deviations or OOS results and communicate shift-level risks to QC leadership.
Utilize electronic systems including LIMS, Biovia (LES, ELN, CIMS/CISPro), and Veeva Vault (QualityDocs, QMS).
Collaborate cross-functionally to meet testing timelines and contribute to continuous improvement initiatives.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications.
Basic Qualifications
High school diploma / GED and 12 years of quality control experience OR
Associates degree and 10 years of quality control experience OR
Bachelors degree and 5 years of quality control experience OR
Masters degree and 3 years of quality control experience OR
Doctorate degree
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
Bachelors degree in a scientific discipline or equivalent experience.
Experience working in a GMP-regulated Quality Control laboratory with demonstrated ability to work independently.
Prior experience serving as a shift lead, point of contact, or informal team lead within a QC laboratory.
Hands-on analytical testing experience in chemistry, bioassay, and/or microbiology.
Strong knowledge of data integrity, GDP, GMP, and 21 CFR Part 11 compliance.
Familiarity with compendial methods (e.g., USPNF).
Excellent communication and organizational skills with the ability to manage multiple priorities in a fast-paced manufacturing environment.
High attention to detail, strong problem-solving skills, and ability to work autonomously during off-shift hours.
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, well support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In Addition To The Base Salary, Amgen Offers a Total Rewards Plan, Based On Eligibility, Comprising Of Health And Welfare Plans For Staff And Eligible Dependents, Financial Plans With Opportunities To Save Towards Retirement Or Other Goals, Work/life Balance, And Career Development Opportunities That May Include
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
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.