Career CategoryOperations
Job DescriptionSr Associate QAWhat you will doLet's do this. Let's change the world. In this vital role you will be responsible for Plant Quality Assurance (PQA) On the Floor in support of Manufacturing activities. This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements. This is an outstanding opportunity to foster a positive relationship and learning environment between Manufacturing and Quality staff, and also to provide coaching, guidance and direction to Manufacturing, Quality Control, and Facilities/Engineering staff regarding compliance and quality systems.
Responsibilities Include:
- Provide Quality oversight to ensure that products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP), and other applicable regulations.
- Provide Quality oversight during on-the-floor analytical testing.
- Ensure that facilities, equipment, materials, processes, and procedures follow cGMPs and other applicable regulations.
- Ensure that deviations from established procedures are investigated and documented per procedures.
- Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
- Perform review and approval of cGMP processes, procedures, and records, including but not limited to, Standard Operating Procedures (SOPs), batch records, deviations, and logbooks.
- Author, review, and approve quality documents such as risk assessments, training materials, engineering documents, automation documents, protocols, and reports.
- Alert senior management of potential quality, compliance, supply, or safety risks.
- Complete assigned training to permit execution of required tasks.
- Drive operational improvement initiatives, programs, and projects.
- Perform other tasks, as assigned, to assist in completion of activities associated with meeting group, departmental, and company goals
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The agile professional we seek is a good collaborator with these qualifications.
Basic Qualifications:
- High school/GED + 4 years Quality Assurance or manufacturing work experience OR
- Associate's + 2 years Quality Assurance or manufacturing work experience OR
- Bachelor's + 6 months Quality Assurance or manufacturing work experience
- Master's
Preferred Qualifications:
- Experience working in a cGMP environment
- Experience with decision making
- Experience with analytical testing and/or general compendia testing
- Experience working with batch records and other GMP documentation
- Knowledge of data integrity requirements
- Proficient in Microsoft Office (e.g., Outlook, Word, Excel, PowerPoint, MS Teams)
What you can expect of usAs 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, we'll 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.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn 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.
Application deadlineAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
SponsorshipSponsorship for this role is not guaranteed.
Salary Range82,081.95USD -111,052.05 USD
