QA Specialist - Digital QA/IS Validation

Initial Therapeutics, Inc.; New Albany (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

Amgen in New Albany, near Columbus, Ohio, seeks a QA Specialist to provide quality oversight for digital systems across manufacturing and warehouse operations, ensuring ALCOA++ and GMP compliance. You will lead cross-functional teams, apply problem solving to validate computer systems, and drive quality governance for electronic records and digital solutions.

Local presence at the New Albany facility is required; sponsorship for this role is not guaranteed.

Qualifications

• Doctorate degree or equivalent in science/engineering
• 2+ years of Quality and/or Manufacturing experience for Master’s
• 4+ years of Quality and/or Manufacturing experience for Bachelor's
• 8 years of Quality and/or Manufacturing experience for Associate
• 10 years of Quality and/or Manufacturing experience for High school diploma

Responsibilities

• Provide quality and compliance guidance for digital manufacturing strategies
• Identify digital advancement opportunities for quality and lead implementation
• Collaborate across Amgen Enterprise/Network for digital solutions
• Review and approve validation documents and quality records
• Ensure documentation meets GMP, Data Integrity and ALCOA++ standards
• Support audits and inspections and interact with regulatory bodies

Skills

Quality Assurance

Regulatory Compliance

GMP Knowledge

Computer Systems Validation

Data Integrity

Education

Doctorate degree

Masters degree with 2+ years QA/Manufacturing

Bachelor's degree with 4+ years QA/Manufacturing

Associate degree with 8+ years QA/Manufacturing

High school diploma with 10+ years QA/Manufacturing

Tools

Trackwise

SAP

LIMS

Vault Quality Docs

PAS-X

Job description

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.

Quality Assurance Specialist

Reporting to the Senior Manager Quality, the QA specialist for the Amgen Advanced Assembly and Final Product Operations facility will provide quality oversight support of the design, installation, commissioning & qualification of business software applications and automated systems. This can cover a wide range of quality processes that drive and govern operations in manufacturing, warehousing and quality assurance for the local site and the Amgen network. The QA specialist will also provide quality oversight for the manufacturing and warehouse digital operations.

This role will require local presence at the New Albany facility near Columbus, Ohio.

What you will do

Lets do this! Lets change the world! At Amgen, we are committed to being science-based and follow a continuous learning approach to advancing science, driving discovery and igniting innovation that works to help reduce disease. It is in this context that we endorse an inclusive and diverse workforce that helps fuel scientific innovation and problem solving, leading to better scientific solutions that benefit both patients and society.

In this vital role you will be responsible for leading and guiding cross functional staff, under general supervision, as an informed Subject Matter Expert in the Digital Quality space related to computer systems validation and electronic records compliance. A key aspect of this role is to apply problem solving skills to ensure quality and compliance to ALCOA++ and GMP regulations for all area operations and associated processes. You will provide Quality oversight of the development and implementation of the digital advancement opportunities for the facility and will lead the digital Quality strategy for the facility.

Responsibilities:

• Provides quality and compliance expertise & guidance and agrees on implementation strategies related to the design, installation, commissioning & qualification, and process qualification of the digital manufacturing strategies for the facility.

• Identify digital advancement opportunities for quality and lead their implementation into the facility while ensuring Quality Processes are adhered to or adjusted as appropriate

• Collaborate cross functionally and across the Amgen Enterprise/Network to ensure digital advancement is implemented in accordance with established procedures and applicable regulations.

• Partner with other facilities in the network to ensure implementation of digital solutions and standard processes, consistency, and continuous improvement.

• Reviews and approves controlled documents, including Standard Operating Procedures, Validation Protocols, Validation Reports.

• Ensures that all activities & related documentation comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Data Integrity, Safety, and Controls.

• Own quality related Standard Operating Procedures, Work Instructions, Forms.

• Ensure relevant processes, equipment, system are validated and the validation is current.

• Support and represent Quality during audits and inspections; may directly interact with regulatory agencies during on-site inspections.

• Support Lean Transformation and Operational Excellence initiatives

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek is a dynamic, flexible and driven individual with these qualifications.

Basic Qualifications:

Doctorate degree

OR

Masters degree and 2 years of Quality and/or Manufacturing experience

Or

Bachelors degree and 4 years of Quality and/or Manufacturing experience

Or

Associates degree and 8 years of Quality and/or Manufacturing experience

Or

High school diploma / GED and 10 years of Quality and/or Manufacturing experience

Preferred Qualifications:

• Masters or Bachelors Degree in Science, Computer Science, Engineering

• Educated in a science, computer science, engineering field with 5 years of experience in GMP operations, ICHs, 21 CFR Part 11, EU Annex 11 and similarly regulated industry

• Affinity with digital innovation, data sciences and Quality engineering

• Computer systems validation knowledge and experience with Automated Systems, Electronic Batch Record, Electronic Quality Management System, IIOT, Digital Control Tower, Advanced Analytics. etc.

• Proficiency with Microsoft Excel, Word, Power Point, Project, Access, and Visio; Adobe

• Acrobat; database related platforms; knowledge of Trackwise, PAS-X, Vault Quality Docs, SAP, LIMS etc.

• Experience in review/approval validation documentation

• Skilled in technical writing and critical reasoning

• Excellent written and verbal communication skills, ability to work in a team matrix environment and establish relationships with partners

• Great attention to detail and high degree of accuracy in task fulfillment and GMP documentation

• Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues

• Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations

• Experience working with dynamic cross-functional teams and demonstrate abilities in decision making

• Strong organizational skills, including ability to follow assignments through to completion

• Strong leadership capabilities and experience applying GMP requirements in an operational setting

• Ability to independently interact with various levels, drives tasks to completion, and is a self-starter.

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

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.