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Senior Associate QA

4 months ago

West Greenwich, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Senior Associate QA Live What you will do Let’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. This position works a rotating night shift (C or D shift), with five days worked during one week (M, Tu, F, Sa, Su) and two days the following week (W, Th). Shift hours are 7pm to 7am. 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 changes that could potentially impact product quality are assessed according to procedures. 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. Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a self-starter with these qualifications. Basic Qualifications: High school diploma / GED and 8 years of Quality/Manufacturing work experience OR Associate’s degree and 6 years of Quality/Manufacturing work experience OR Bachelor’s degree and 2 years of Quality/Manufacturing work experience OR Master’s degree Preferred Qualifications: Bachelor’s degree and 2 years of Quality/Manufacturing work experience Experience working in a cGMP environment 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) Experience collaborating within and across functional areas and demonstrated customer service focus Excellent written and verbal communication skills Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being. 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. Amgen offers a Total Rewards Plan comprising 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 including: 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 and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. 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.