QA Specialist

Initial Therapeutics, Inc.; New Albany (OH); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock-based incentives

Job summary

Amgen Ohio (AOH) seeks a Specialist QA to drive quality operations in the Final Drug Product plant. You will lead cross-functional teams, approve critical documents, and ensure GMP compliance while addressing deviations and CAPAs.

You will partner with Manufacturing, QC, Engineering, and Supply Chain to uphold record integrity, enable timely batch disposition, and support audits. The role emphasizes continuous improvement and adherence to safety and quality standards.

Qualifications

• Doctorate, or Master’s with 2 years QA/Manufacturing experience
• Bachelor’s with 4 years QA/Manufacturing experience
• Associates with 8 years QA/Manufacturing experience
• High school diploma with 10 years QA/Manufacturing experience
• Experience with GMP/GCP operations or regulated industry

Responsibilities

• Review and approve controlled documents (SOPs, validation docs)
• Provide quality oversight for quality records and deviations/CAPAs
• Lead investigations and deviations resolutions
• Ensure compliance with GMP requirements and records disposition
• Support audits and inspections by regulatory agencies
• Contribute to Lean Transformation and Operational Excellence initiatives

Skills

Quality oversight

Investigations

Regulatory inspections

Education

Doctorate degree

Master's degree

Bachelor's degree

Associates degree

High school diploma

Tools

SOPs

Validation Protocols

Validation Reports

Electronic Master Batch Records

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.

Specialist QA

What you will do

Lets do this. Lets change the world. In this role you will have the opportunity to be part of the continued expansion of Quality Operations at Amgen Ohio (AOH) supporting our growing state-of-the-art Final Drug Product (FDP) Plant. You will lead and direct cross functional staff as an informed Subject Matter Expert in the Quality deliverables. A key aspect of this role is to apply critical thinking skills to ensure quality and compliance to GMP regulations for operations and associated processes. Duties include oversight on daily manufacturing operations, development and approval of standard operating procedure, quality approval of deviations and final batch disposition. Responsibilities will include evaluation of compliance and quality issues, providing recommendations for improvement projects, and assuring progress of records to completion.

• Review and approve controlled documents, including Standard Operating Procedures, Validation Protocols, Validation Reports, Electronic Master Batch Records etc.
• Provide quality oversight for quality records including deviations/CAPAs, technical change controls and work orders assuring adherence to procedural requirements and confirming assessments and evaluations of different partners are complete and accurate
• Driveinvestigations and resolution of deviations, ensuring timely, thorough, and compliant outcomes
• Ensure that all activities & related documentation for facilities, equipment, materials and processes align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
• Own quality related Standard Operating Procedures, Work Instructions, Forms and Methods and ensuredocument control excellence, including timely periodic review of controlled documents
• Provide quality oversight for manufacturing and be responsible for batch disposition.
• Provide quality and compliance expertise & guidance and agrees on strategies related to process lifecycle management.
• 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

• Ensureproduction records and test resultsare accurate, complete, and inspection-ready
• Champion and leadcontinuous improvement initiativesto strengthen quality systems and operational performance
• Partner cross-functionally with Manufacturing, QC, Engineering, Supply Chain, and other stakeholders

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

• Master's or Bachelors Degree in Science
• Educated in a science field with 5 years of experience in GMP/GCP operations or similarly regulated industry
• Affinity with digital innovation, data sciences and Quality engineering
• Experience in review/approval validation documentation
• Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues
• Ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations
• Experience working with dynamic cross-functional teams and 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.

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.

for a career that defies imagination

Objects in your future are closer than they appear. Join us.