Sr. Associate QA - Warehouse Technical Operations (Tuesday - Saturday)

BioSpace; New Albany (OH); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading biotech company is seeking a Sr. Associate in Quality Assurance to enhance warehouse technical operations. The successful candidate will provide QA oversight, ensure compliance with GMP, and support the warehouse's operational excellence. A collaborative and innovative environment awaits, alongside a competitive benefits package.

Benefits

Comprehensive employee benefits package

Retirement and Savings Plan

Discretionary annual bonus program

Stock-based long-term incentives

Flexible work models

Qualifications

• 4+ years in Quality Assurance preferred.
• Experience with compliance and good manufacturing practices (GMP).
• Strong documentation skills in QA processes.

Responsibilities

• Provide QA guidance and support to warehouse operations.
• Review and approve quality documentation and compliance.
• Mentor warehouse staff on quality procedures.

Skills

Quality Assurance

Compliance

Documentation

Team Mentorship

GMP Operations

Education

High school/GED + 4 years QA experience

Associates + 2 years QA experience

Bachelor's + 6 months QA experience

Job description

Sr. Associate QA - Warehouse Technical Operations (Tuesday - Saturday)

Sr. Associate QA - Warehouse Technical Operations (Tuesday - Saturday)

6 days ago Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

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. 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.

Sr. Associate QA - Warehouse Technical Operations

What You Will Do

Lets do this. Lets change the world. In this role as Senior Associate QA, you will be mainly responsible for providing QA guidance and support to AOH warehouse Operation and performing Quality Review of all inbound and outbound related documentation at AOH. Next to that, you will provide support in different QA related projects/systems. In this role, you will be in direct contact with a wide range of partners, and you will be accountable for establishing effective working relationships with warehouse supervisors and staff, Incoming QA and production leads, production and facilities and engineering.

The Sr. Associate QA for the new Amgen Advanced Assembly and Final Product Operation facility will be part of the Quality Assurance Floor Support team providing QA oversight to the warehouse operations. The Sr. QA Associate will support multiple warehouse functions (from the receiving of materials to the shipping of finished goods) to achieve site goals while providing Quality oversight and ensuring compliance. Supporting resolution of potential nonconformance events by using the deviation and CAPA management procedure, in conjunction with other procedures as applicable, to facilitate decision-making with Warehouse, IQA, and other groups, as needed. Advising staff on proper documentation as needed and performing other duties as assigned. This role will require local presence at the New Albany facility near Columbus, Ohio.

• Provide daily guidance and support to warehouse staff regarding compliance with Standard Operating Procedures and Work Instructions.
• Ensure regular presence in the warehouse area to provide oversight to GMP operations and quality systems.
• Act as a first point of contact in case of production warehouse staff inquiries (quality related) during operations.
• Lead, mentor, and coach personnel on quality matters, while driving the site Quality culture.
• Review and approve inbound and outbound processes and other GMP documentation in support of daily operations.
• Own, review, and approve controlled documents, including Standard Operating Procedures (SOPs), Work Instructions and Forms.
• Review and approve Deviation, CAPA, and Change Control records.
• Participate in self-led inspections and provide support during internal / external regulatory inspections.
• Support Lean Transformation and Operational Excellence initiatives.
• Adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting Environmental Health and Safety corporate and site goals
  
  
  

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 assurance work experience

Or

Associates + 2 years quality assurance work experience

OR

Bachelors + 6 months quality assurance work experience

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, including remote and hybrid work arrangements, where possible
  
  
  

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.

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Internet News

Referrals increase your chances of interviewing at BioSpace by 2x

Get notified about new Senior Quality Assurance Specialist jobs in New Albany, OH.

Quality Assurance - Quality Control Columbus Manager

(USA) Area Manager, Quality Assurance/Systems

Groveport, OH $65,500.00-$98,000.00 49 minutes ago

Columbus, OH $75,000.00-$90,000.00 1 week ago

Sr. Specialist, Quality Assurance - QC Oversight

Senior QA Specialist/CAPA Investigations

LEAD Quality Assurance Specialist - Hybrid, OH

LEAD Quality Assurance Specialist 4 - Hybrid, OH

Senior Specialist, Quality Assurance - Research & Development

(USA) .com Quality Assurance Assoc (Sortable)

(USA) .com Quality Assurance Assoc (Sortable)

(USA) .com Quality Assurance Assoc (Sortable)

KYC Quality Assurance Data and Technology Business Analyst, Associate II

Manager, Quality Assurance Engineer AI/ML

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.