What are the responsibilities and job description for the Sr Associate PQA 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.
Senior Associate Quality Assurance
What You Will Do
Lets do this. Lets change the world. At Amgen, our mission is simple yet powerful: to serve patients. At our Ohio site, youll play a critical role in ensuring the highest standards of quality in the products that impact lives around the world. Were looking for a Senior Associate in Quality Assurance who brings energy, precision, and a passion for excellence to our growing team.
If you thrive in a fast-paced, regulated environment and enjoy solving complex challenges, this is your opportunity to make a meaningful difference.
Responsibilities
As a Sr. Associate in QA, you will be a key player in maintaining compliance and driving quality across manufacturing operations. Your responsibilities will include:
What We Expect Of You
We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek will possess these qualifications.
Basic Qualifications
High school/GED 4 years quality work experience
OR
Associates 2 years quality work experience
OR
Bachelors 6 months quality work experience
OR
Master's
Preferred Qualifications
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
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.
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.
Senior Associate Quality Assurance
What You Will Do
Lets do this. Lets change the world. At Amgen, our mission is simple yet powerful: to serve patients. At our Ohio site, youll play a critical role in ensuring the highest standards of quality in the products that impact lives around the world. Were looking for a Senior Associate in Quality Assurance who brings energy, precision, and a passion for excellence to our growing team.
If you thrive in a fast-paced, regulated environment and enjoy solving complex challenges, this is your opportunity to make a meaningful difference.
Responsibilities
As a Sr. Associate in QA, you will be a key player in maintaining compliance and driving quality across manufacturing operations. Your responsibilities will include:
- Providing on-the-floor QA support for manufacturing activities across assigned shifts
- Ensuring adherence to GMP regulations and internal quality standards
- Reviewing and approving batch records, logbooks, and quality documentation
- Supporting deviations.
- Partnering cross-functionally with Manufacturing, QC, and Engineering teams
- Identifying opportunities for continuous improvement and operational excellence
- Acting as a quality advocate, promoting a culture of compliance and accountability
What We Expect Of You
We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek will possess these qualifications.
Basic Qualifications
High school/GED 4 years quality work experience
OR
Associates 2 years quality work experience
OR
Bachelors 6 months quality work experience
OR
Master's
Preferred Qualifications
- Bachelors degree in Life Sciences, Engineering, or related field
- 1 years of experience in Quality Assurance within a GMP environment (biotech/pharma preferred)
- Strong knowledge of cGMP regulations and industry best practices
- Experience with batch record review, and deviations
- Ability to work flexible shifts, including evenings, nights, weekends, or holidays as needed
- Excellent communication, problem-solving, and organizational skills
- A proactive mindset with a strong attention to detail
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.
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.
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.