Specialist QA- US Remote

BioSpace; Washington (District of Columbia); Remote; USD 80,000 - 110,000; Full time

Job summary

A leading biotechnology company is seeking a Specialist QA to provide quality assurance support within the Product Quality organization. The role involves collaborating across various functional areas and ensuring compliance with quality systems and regulations. Candidates should possess relevant educational qualifications and experience in quality assurance, with a focus on biopharmaceuticals. The company offers competitive benefits and opportunities for professional growth.

Benefits

Health plans

Bonuses

Stock incentives

Flexible work arrangements

Qualifications

• Experience with biopharmaceutical manufacturing and QC testing.
• Understanding of pharmaceutical sciences, quality, compliance, and regulatory requirements.

Responsibilities

• Provide QA systems expertise and support to the Product Quality organization.
• Review and approve documents and execute transactions in GMP systems.

Skills

Quality Assurance

Project Management

Communication

Education

Doctorate degree

Masters degree

Bachelor's degree

Associate's degree

High school diploma/GED

Tools

VEEVA

Trackwise

Job description

Join to apply for the Specialist QA - US Remote role at BioSpace.

Join Amgen's mission of serving patients.

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.

Since 1980, we've helped pioneer the biotech industry in our fight against the world's toughest diseases. With a focus on Oncology, Inflammation, General Medicine, and Rare Disease, we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on patients' lives by researching, manufacturing, and delivering innovative medicines to help people live longer, fuller, and happier lives.

Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities they present, you'll thrive at Amgen. Join us to transform lives and your career.

Specialist QA

What You Will Do

This vital role involves providing quality assurance support to the Product Quality organization as a subject matter expert in quality systems and records. You will collaborate within PQ and with various functional areas such as Supply Chain, Manufacturing, Quality Control, Regulatory, and more, on projects, issue resolution, and investigations.

The QA Specialist will use technical skills and knowledge of QMS processes, procedures, and regulations to lead QA responsibilities, review, and approve Product Quality records and documentation including specifications, reports, reviews, change controls, investigations, CAPAs, and procedures. You may also approve commercial variation records (GDCR) and provide training to staff.

Responsibilities

• Provide QA systems expertise and support to the Product Quality organization, working within a team environment.
• Support QA tasks for clinical and commercial products, working directly with Product Quality Leaders.
• Review and approve documents and execute transactions in GMP systems like Veeva CDOCs and Trackwise.
• Support audits, inspections, and continuous improvement initiatives.
• Interact with various functional areas within Amgen.

What We Expect From You

We value diverse contributions to serve patients. The qualifications include:

Basic Qualifications

• Doctorate degree
• Or Masters degree with 2 years' experience
• Or Bachelor's degree with 4 years' experience
• Or Associate's degree with 8 years' experience
• Or High school diploma/GED with 10 years' experience

Preferred Qualifications

• Understanding of pharmaceutical sciences, quality, compliance, and regulatory requirements.
• Experience with biopharmaceutical manufacturing and QC testing.
• Experience with VEEVA, Trackwise, and other Amgen quality systems.
• Experience reviewing GMP documentation.
• Strong investigation and change control experience.
• Project management skills and ability to work in a matrix environment.
• Excellent communication, facilitation, and presentation skills.

What You Can Expect From Us

We support your professional and personal growth with competitive benefits, a collaborative culture, and opportunities for development. The salary range is posted but varies based on skills and experience. Benefits include health plans, bonuses, stock incentives, time-off, flexible work arrangements, and more.

Apply now and make a lasting impact with Amgen. Visit careers.amgen.com.

Amgen is committed to diversity and inclusion. We consider all qualified applicants and provide accommodations for applicants with disabilities.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Quality Assurance