Senior Associate, On-the-Floor, Plant QA - Night Shift (Chepachet)
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Under minimal supervision, this position is primarily responsible for performing quality review of documentation to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations. Duties focus on providing quality guidance during on-the-floor manufacturing activities.
The initial focus of this role will be on the AR 30 startup during Admin Day shift to prepare the new facility for Operational Readiness. After the facility startup phase, the successful incumbent will be expected to transition to a 12-hour shift working schedule. The shift pattern will be 7PM - 7AM with a rotation covering 7 days per week.
The rotating 12-hour night shift offers several benefits, with an average of 14 days on shift per month with every other weekend off. In addition, the night shift is eligible for a shift differential and any Sundays worked receive Premium pay.
Support AR 30 startup activities for facilities, utilities, equipment and systems including:
Author/review quality documents, related to: SOPs, user requirements, risk assessments, training materials, engineering, automation, commissioning, facility, utility, environmental qualification, validation.
Support execution of, and change management related to, the following: site acceptance, commissioning tests, facility qualifications and validation activities.
Execute daily operations per management guidance in a dynamic environment.
Perform OTF (on-the-floor) quality review of documents, such as: equipment logs, training records, testing results, batch records and supporting documents.
Perform daily OTF inspections to ensure facilities, equipment, materials and documentation comply with SOPs and safety standards.
Provide guidance during on-the-floor analytical testing.
Support audits, inspections and investigations.
Adhere to LEAN practices and contribute to culture of continuous improvement.
Bachelor's Degree and 2 years of Quality or Manufacturing experience
Associate's degree and 6 years of Quality or Manufacturing experience
High school diploma/GED and 8 years of Quality or Manufacturing experience
Strong cGMP and GDP behaviors
Demonstrated experience with deviations and CAPA (corrective action/preventative action) records
Knowledge of electronic systems including LIMS (laboratory information management system), Trackwise and Maximo
Strong word processing, presentation, database and spreadsheet application skills
Strong organizational skills and ability to manage multiple tasks at one time
Ability to follow assignments through to completion and meet timelines
Exposure to regulatory agency inspectors or participation in regulatory agency audits
Strong technical communication skills, both written and oral
Demonstrated ability to work as a team player and independently
Open to travel
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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. Associated topics: defect, qa, quality, quality assurance, quality check, quality control, quality control/quality assurance, quality manager, requalification, test