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Sr Associate QA - Nights
Amgen
- West Greenwich, Rhode Island, United States
- West Greenwich, Rhode Island, United States
Über
Responsibilities
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‑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 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 meeting group, departmental and company goals.
Basic Qualifications
High school or GED plus 4 years of quality assurance or manufacturing work experience.
Associate’s degree plus 2 years of quality assurance or manufacturing work experience.
Bachelor’s degree plus 6 months of quality assurance or manufacturing work experience.
Master’s degree.
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.
Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint, MS Teams).
Benefits 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 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 toward 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.
Equal Opportunity Employer 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 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.
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Sprachkenntnisse
- English
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