Amgen Specialist Quality Control in Juncos, Puerto Rico
The Specialist Quality Control under general direction will act as the technical specialist for analytical method transfers, method validations, new product introduction and laboratory support. Focus is on complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources.
This role is crucial for Amgen's success and it will be a key contributor in the Quality Control Department.
SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
Responsible for providing technical guidance.
Provide reports and data analysis.
Ensure flow of communication between technical groups including following-up and resolving issues that arise.
Resolve technical issues and troubleshoot for assays as necessary.
Ensure lab compliance - which includes implementing procedures that enhance cGMP, GLP and safety.
Manage existing and/or develop and implement new programs, processes and methodologies.
Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact.
Support lab investigations and lead audit teams.
May serve as subject matter expert to develop technical training.
Represents the department/organization on various teams.
Independently responsible for following through on multi-site action items.
May interact with regulatory agencies regarding area(s) of responsibility including written responses.
May resolve issues with outside resources.
Performs special projects as requested by supervisor.
May supervise employees as necessary to meet technical requirements.
Master's degree and 3 years of quality control experience
Bachelor's degree and 5 years of quality control experience
PhD, B.S. or M.S. educational background with a major in Chemistry
Experience with transfer and validation of analytical methodology.
Understand, support and demonstrate the AMGEN values.
Excellent communication skills, facilitation and presentation skills.
Excellent technical writing skills.
Strong computer operation skills including work processing, presentation, database and spreadsheet application skills.
Project management and organizational skills including the ability to independently understand, follow, implement complex instructions and follow assignments through to completion.
Skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities.
Excellent knowledge of and experience with processes involved in quality analytical labs, validation, manufacturing, quality assurance, process development and distribution.
Knowledge of all testing including the development and validation of assays and the ability to perform all testing in specific area of responsibility.
Knowledge of pharmaceutical processes.
Knowledge of U.S. regulations and practices pertaining to the testing of pharmaceutical/biological products.
Knowledge of basic international regulations and practices pertaining to the testing of pharmaceutical/biological products.
Knowledge and application of cGMPs/CFRs.
Ability to evaluate compliance issues. Skill in evaluating and documenting according to Company and various guidelines.
Proficient at maintenance, troubleshooting and operation of equipment in area of expertise.
Scientific data analysis and interpretation skills.
Skills in solving complex problems.
Data trending and evaluation.
Skill in working independently and to effectively interact with various levels.
Ability to interact with regulatory agencies both orally and in writing.
Initiate, coordinate and lead cross functional teams.
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.