Amgen Work Values

Daily Duties at Amgen:

Hired, managed, trained, scheduled and promoted career development of QA professionals and auditors responsible for cGMP and Quality Assurance Unit (QAU) audits for site QA and vendors. Ensured appropriate and effective cross-training in compliance areas. Ensured that all audits were assigned to appropriately trained auditors, conducted effectively, and reported accurately in a timely manner to ensure a state of site audit readiness. Instrumental in BLA filing, Validations, Quality Systems, Training and Quality Procedures. • Independently determines approach to managing daily quality operations. • Interprets and executes policies that directly affect work activities • Develops and communicates plans/objectives to others • Set project timeframes and priorities based on project objectives and ongoing assignments as well as coordinate assignments. • Monitors department budgets and goals • Provide guidance and technical advice to staff members as well as client groups. • Facilitate Department and QA Mangers meetings • Frequent contact with internal personnel and outside customer representatives at various management levels to obtain and allocate resources and complete specific phases of projects. • Accountable for day-to-day Quality operations and responsibilities. • Training Head for site Plant Quality Assurance: Responsible for training development and updates. • Able to apply knowledge to provide appropriate risk based decisions. • Involved in contamination response meetings as Quality representative. • Continue to develop staff into high performers and qualified quality representatives. • Validation, SOP, Tech reports, MP reviewer and approver. • Applies influence and negotiation skills to drive business results. • Involved in FDA audits and costumer complaints. • In support of Amgen's Quality Assurance program; manages and oversees the QA operations of a specific functional area in a manufacturing plant. • Responsible for hiring, training, supervising and performance management of staff. Perform or oversee the following functions: Initiate or review change control packages. • Review and approve product MPs Review and approve SOPs. • Approve process validation protocols and reports for Mfg. processes. • Approve Environmental Characterization reports Approve planned incidents Lead investigations • -Lead plant audits, participate in site audits Approve changeover completion. • General document coordination and compilation • Prepare micro. Certificates, ALN, QDS • Compliance review of batch record elements (e.g., MPs, MSRs) and identification of discrepancies • Work with operations to resolve basic compliance discrepancies • Approve micro. Certificates and ALNs • Disposition of raw materials, components, and labels. • Ensure that new hires have the essential tools and resources to do their job successfully. • Implement my leadership and communication skills, finding ways to improve new-hires transaction periods, making employees more productive sooner. • Maintain a system to accommodate any Amgen or Quality personnel changes i.e. ISOtrain; SOP rev(s), Master Record updates. • Work with HR Dept to modify ISOtrain for PQA needs for tracking new SOP rev(s) and keeping employee training concurrent by at least 90%. • Set up PQA Training Modules. • Train Bio Next personnel involving SOP(s), Databases, and PQA procedures. • Set up Documented practices for PQA Dept. as well as a system to track training of this procedure, this will assist PQA personnel and Management on document flow as well as new hires will have a enhanced perceptive of Amgen(s) practices. • Set up Training Qualifications for Process Services Batch records. • Set up Training Qualifications for Cell Culture Batch records. • Set up Training Qualifications for Purification Batch records. • Set up Training Qualifications for Quality systems. • Set up Training Qualifications for Lot Disposition. • Collaborate and communicate with higher level outside resources. • Ability to evaluate compliance risks. • Thorough knowledge of CFRs, GMPs and pharmaceutical processing • Approve and monitor Supplier CAPA plans

What they like about Amgen:

Organizations with strong, centralized leadership are particularly attractive to you. You require a work environment with leadership that aggressively seeks to expand and grow the business and does so in a visible and decisive manner. In general you prefer to work in an environment in which there is a strong link between leadership, its actions, and a strong set of company-wide values.

Tags

Skills

CAPA, Trackwise, ERP, SOP, Change Control, Master Batch Records, IQ OQ PQ PV validations, 10 plus years Mgt, Audits, cGMP - GLP, FDA - EU - Aduits, Investigations

These are some of the questions we asked our climbers about their experiences with Amgen: