Sr Associate QC-Bio-assay Lab

SUMMARY

The Sr Associate QC role will be responsible for one or more of the following activities in Quality Control including analytical testing, characterization, method development and validation, cell culture and maintenance, and sample and data management in a Non Standard Shift operations.

SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

• Perform routine laboratory procedures
• May perform aseptic aliquot ting, sampling and analysis for compendia and non-compendia methods
• May perform non-routine lab procedures under close supervision
• Perform Cell culture and Maintenance
• Use and Maintenance of Automation equipment
• Perform qualification of Critical Reagents and material
• Perform or review one or more of the following: sample testing, standards preparation and testing procedures, compendia and non-compendia test methods, environmental monitoring, reagents and solutions preparation, sample management and equipment maintenance
• Prepare complete, accurate, concise laboratory documentation
• Data entry, review, analysis and communication of results
• Perform general lab housekeeping
• Maintain/operate specialized equipment
• Participate in the document revision process
• Follow safety guidelines, cGMPs and other applicable regulatory requirements
• Maintain training proficiency*
• Plan and perform routine analyses with greater efficiency and accuracy*
• May provide technical mentorship
• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays
• Report, evaluate, back-up/archive, trend and approve analytical data
• Troubleshoot, tackle problems and communicate with partners
• Initiate and/or implement changes in controlled documents
• May train others as necessary
• Participate in audits, initiatives and projects that may be departmental or organizational in scope
• Write protocols and perform assay validation and equipment qualification/ verification
• Introduce new techniques to the lab, including method transfers, reports, validations and protocols
• May contribute to regulatory filings
• May conduct lab investigations as necessary
• Evaluate lab practices for compliance on a continuous basis
• Approve lab results
• May represent the department/organization on various teams
• May interact with outside resources

Knowledge:

• Understanding and application of principles, concepts, theories and standards of technical/scientific field
• Specialized knowledge within own specialty area
• Deepens technical knowledge through exposure and continuous learning
• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery

Problem Solving:

• Applies research, information gathering, analytical and interpretation skills to problems of diverse scope
• Ensures compliance within regulatory environment
• Develops solutions to technical problems of moderate complexity
• Screens, categorizes, evaluates, reconciles, reports and resolves data integrity issues
• Interprets generally defined practices and methods

Autonomy:

• Works under general direction
• Work is guided by objectives of the department or assignment
• Refers to technical standards, principles, theories and precedents as needed
• May set project timeframes and priorities based on project objectives and ongoing assignments
• Recognizes and calls out problems

Contribution:

• Contributes to work group/team by ensuring the quality of the tasks/services provided by self
• Contributes to the completion of achievements associated with specific projects or activities within own department or workgroup
• Provides training/mentorship to others and acts as a technical/scientific resource within work group/team
• Establishes working relationships with others outside area of expertise

BASIC EDUCATION/EXPERIENCE

Bachelor's degree and 2 years of laboratory experience in a GMP regulated environment
Or

Master's degree

PREFERRED QUALIFICATIONS

• Educational background in Biotechnology, Biochemistry, Immunology, Microbiology and/or Molecular Biology
• Strong Knowledge of Potency Assays or Cell based assays, Immunoassays, ELISA, Dot Blot, and/or Serology
• Proficiency on culture and maintenance of immortalized eukaryotic cell lines
• Knowledge on Automation systems like liquid Handling systems and Cell counters
• Knowledge on Flow Cytometry techniques
• Knowledge on Operational Excellence tools (Continuous Improvement)
• Strong Background in Sample Preparation (aliquoting, serial dilutions)
• Strong skills in manual and/or electronic micropipettes use
• Good mathematical skills
• Project management skills
• Strong organizational skills, including ability to follow assignments through to completion
• Initiate and lead cross functional teams
• Enhanced skills in leading, influencing and negotiating
• Strong knowledge in area of expertise
• Collaborate and coordinate with higher level outside resources
• Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development
• Demonstrate ability to interact with regulatory agencies
• Strong word processing, presentation, database and spreadsheet application skills
• Strong communication (both written and oral), facilitation and presentation skills
• Strong skill in working independently and to effectively interact with various levels
• Advance data trending and evaluation
• Ability to evaluate compliance issues

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.