The Quality Assurance Specialist will be responsible for Quality Validation, PQA On the Floor and Off the Floor activities, and may include Raw Materials and Drug Substance Disposition for Quality Assurance 1st Shift/administrative shift. 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 and deviations. This is a unique opportunity to foster a strong partnership and learning environment between Manufacturing and Quality staff. The focus of this role will be to support Quality Validation activities but may include PQA On the Floor and Off the Floor, Raw Materials and Drug Substance Disposition activities as required by the needs of the department. Amgen's Quality Assurance Shift 1/Administrative shift provides coaching, guidance and direction to Manufacturing, Quality Control, Process Development, Supply Chain and Facilities & Engineering staff regarding compliance and quality systems.
Responsibilities include the following:
Provide Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
Ensure that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations.
Quality review and approve Validation Documents including: DT, CRSIQ/OQ, RTM, FT/FTF, protocols, and reports.
Perform ownership, QA review, and QA approval of cGMP processes, procedures, documents and records, including but not limited to Nonconformance, Corrective Action/Preventative Actions (CAPA), Change Control records, validations, and Raw Materials and Drug Substance documentation.
Author/review/approve quality documents, such as: SOPs, user requirements, risk assessments, training materials, engineering documents, automation documents, environmental qualification protocols/reports, validation protocols/reports.
Establish and enable LEAN practices.
Oversee and provide guidance during on-the-floor analytical testing.
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.
Alert senior management of quality, compliance, supply and safety risks.
Complete required assigned training to permit execution of required tasks.
Drive operational improvement initiatives, programs and projects.
Master's degree and 3 years of Quality, Manufacturing, Process Development or Process Engineering experience
Bachelor's degree and 5 years of Quality, Manufacturing, Process Development or Process Engineering experience
Associate's degree and 10 years of Quality, Manufacturing, Process Development or Process Engineering experience
High school diploma / GED and 12 years of Quality, Manufacturing, Process Development or Process Engineering experience
Scientific degree in Life Sciences or Physical Sciences or Applied Engineering or Manufacturing Technologies
Previous QA oversight of manufacturing, analytical and engineering activities
Experience in investigations, change controls, and CAPAs processes system knowledge
Direct Validation experience with pharmaceutical or biopharmaceutical processes
Ability to evaluate compliance issues and interact with regulatory inspectors
Experience and training in EDMQ, Trackwise, Maximo, LIMS
Experience in managing multiple, competing priorities in a fast-paced environment
Experience leading and/or managing teams
Direct bulk drug substance and drug product experience
Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff.
Ability to solve complex problems and make scientific risk-based decisions
Experience representing Amgen while interacting with representatives of regulatory agencies
Experience of trending analysis
Demonstrated proficiency using Excel, Word and Power Point
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.
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: automation, performance test, qa, quality, quality assurance, quality assurance lead, software quality, software quality engineer, test engineer, tester