Amgen Aseptic Officer in Thousand Oaks, California

Responsible for the manufacturing aseptic technique program including routine observation of critical processes, coaching and mentoring on aseptic technique, trending of observations, implementation of corrective actions, and ownership of the environmental monitoring (EM) heat map. B20 Manufacturing representative for the Environmental Monitoring Program, partnering with Quality Control program owner and Quality Assurance Aseptic Officer on review of data trend reports, metrics, EM protocols/reports, SOPs, interacting with and/or presenting to internal and external inspectors, and supporting non-conformance investigations.

Aseptic Officer Program Owner

  • Execute routine observations of aseptic processes, trend the observations and lead corrective actions as required

  • Provide coaching and mentoring on aseptic technique

  • Create and review relevant procedures for completeness and accuracy

  • Partner with Quality Assurance Aseptic Officer

  • Partner with Aseptic Officers at other sites

  • Must comply with safety guidelines

  • Must comply with cGMPs/CFRs which includes, but is not limited to, the maintenance of training records and written procedures.

B20 Environmental Monitoring Program representative

  • Provide technical support for evaluating changes and impact on the EM program

  • Support the review/approval of EM data trend reports, metrics, EM protocols/reports, SOPs

  • Interact with and/or present to internal and external inspectors

  • Support non-conformance investigations

Change Control

  • Provide environmental monitoring input on assessment of change control records as required

Non-Conformance

  • Support non-conformances and investigations as a subject matter expert

Operational Excellence

  • Own and participate in Lean Transformation activities (e.g., SQDIP boards, Work Center Teams)

  • Champion improvement opportunities cross functionally and use continuous improvement tools and methodology, (e.g. 5S, Kaizen, Smart Ideas)

Basic Qualifications:

Doctorate degree

OR

Master's degree and 3 years of operations or quality experience

OR

Bachelor's degree and 5 years of operations or quality experience

OR

Associate's degree and 10 years of operations or quality experience

OR

High school diploma / GED and 12 years of operations or quality experience

Preferred Qualifications:

Experience:

  • 10 years of bio-pharmaceutical and/or medical technology experience with increasing responsibility in the organization

  • A Bachelor's or Master's degree in Microbiology, Life Sciences or a related field

  • Experience working in an aseptic environment

  • Experience working in or supporting a Manufacturing environment

  • Experience working with internal and external inspectors

Knowledge:

  • Knowledge of microbiology analytical and identification techniques

  • Knowledge and experience with cGMP regulations, practices and compendia requirements pertaining to the manufacturing and testing of biopharmaceuticals,

  • Knowledge and experience with data trending, metrics generation, authoring protocols/reports, and authoring SOPs

  • Knowledge and experience with Micro excursion investigations associated with EM, bioburden, or utility samples

  • Knowledge and experience using the MSDS

  • Knowledge with processes involved in manufacturing and distribution, QA, QC, validation and process development

  • Ability to evaluate documentation/ operations according to company procedures

  • Knowledge in continuous improvement tools and methodologies

  • Familiarity with Lean Transformation process and associated Operational Excellence tools

  • Ability to make decisions in a timely and thoughtful manner, taking in consideration available information

  • Ability to respond appropriately if a situation requires a different set of skills and work approaches

  • Ability to meet expectations and requirements of internal and external customers

  • Ability to assimilate information and make timely decisions that impact the functional area

Skills:

  • Aseptic technique skills

  • Problem solving skills

  • Technical writing skills for investigation

  • Communication (verbal and written) at all levels

  • Statistical analysis tools to perform data trending and evaluation

  • Investigation skills

  • Presentation skills

  • Negotiation skills

Competencies:

  • Related quality control or manufacturing experience in the pharmaceutical or medical device industry

  • Attention and dedication to quality

  • Team player

  • Ability to organize work, handle multiple priorities and meet deadlines

  • Flexible and adaptable to changing priorities and requirements

  • Demonstrates understanding of when and how to appropriately escalate

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.