Aseptic Officer Thousand Oaks, CA
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Job Location:
Thousand Oaks, CA - USA
Monthly Salary:
$ 139179 - 139179
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.
At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.
Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Aseptic Officer
What you will do
Lets do this. Lets change the this vital role you will provide technical leadership and oversight of aseptic operations within the multi-product drug product manufacturing facility. This role is accountable for maintaining compliance with cGMP requirements through robust execution of the aseptic technique and media fill programs and by supporting contamination control initiatives across operations. You will own the Media Program for one of two isolator-based filling lines lead observation and training efforts to sustain aseptic compliance and partner cross-functionally with Quality Validation and Engineering to ensure sterility assurance standards are consistently met.
Responsibilities:
Aseptic Program Leadership
Lead the Aseptic Technique Program for the suite including routine observation of critical operations data trending and implementation of corrective and preventive actions (CAPAs).
Provide coaching and mentoring to operations personnel to strengthen aseptic practices and contamination control awareness.
Author review and maintain aseptic-related SOPs reports and training materials to ensure alignment with current regulatory expectations and site standards.
Partner closely with Quality Assurance Validation and other site Aseptic Officers to ensure consistent execution and knowledge sharing across functions.
Represent Manufacturing during internal and external inspections demonstrating robust understanding and control of aseptic practices.
Media Fill Program Ownership
Lead the Media Fills supporting the sites one of two isolator-based filling lines.
Author and implement media fill protocols complete final reports and perform data trending and risk analysis.
Partner with Manufacturing Quality and Engineering to ensure execution aligns with aseptic process design batch records and contamination control strategy.
Evaluate results find opportunities for process or operator improvement and ensure timely closure of associated investigations and CAPAs.
Contamination Control and Compliance Support
Support contamination and cross contamination control initiatives and provide aseptic expertise in investigations deviations and change controls.
Participate in data reviews and trending related to aseptic or microbiological quality indicators (e.g. EM bioburden or utility monitoring) as needed.
Contribute to improvements in facility design procedures and behaviors that enhance aseptic performance and sterility assurance.
Participate in partner and regulatory audits provide required information and respond to findings as appropriate.
Operational Excellence
Actively participate in Lean Transformation and continuous improvement initiatives (e.g. SQDIP boards Kaizen events and Work Center Teams).
Use problem-solving and root-cause tools (5S Fishbone 5 Whys) to identify and implement improvements to aseptic performance and process control.
At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.
Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Aseptic Officer
What you will do
Lets do this. Lets change the this vital role you will provide technical leadership and oversight of aseptic operations within the multi-product drug product manufacturing facility. This role is accountable for maintaining compliance with cGMP requirements through robust execution of the aseptic technique and media fill programs and by supporting contamination control initiatives across operations. You will own the Media Program for one of two isolator-based filling lines lead observation and training efforts to sustain aseptic compliance and partner cross-functionally with Quality Validation and Engineering to ensure sterility assurance standards are consistently met.
Responsibilities:
Aseptic Program Leadership
Lead the Aseptic Technique Program for the suite including routine observation of critical operations data trending and implementation of corrective and preventive actions (CAPAs).
Provide coaching and mentoring to operations personnel to strengthen aseptic practices and contamination control awareness.
Author review and maintain aseptic-related SOPs reports and training materials to ensure alignment with current regulatory expectations and site standards.
Partner closely with Quality Assurance Validation and other site Aseptic Officers to ensure consistent execution and knowledge sharing across functions.
Represent Manufacturing during internal and external inspections demonstrating robust understanding and control of aseptic practices.
Media Fill Program Ownership
Lead the Media Fills supporting the sites one of two isolator-based filling lines.
Author and implement media fill protocols complete final reports and perform data trending and risk analysis.
Partner with Manufacturing Quality and Engineering to ensure execution aligns with aseptic process design batch records and contamination control strategy.
Evaluate results find opportunities for process or operator improvement and ensure timely closure of associated investigations and CAPAs.
Contamination Control and Compliance Support
Support contamination and cross contamination control initiatives and provide aseptic expertise in investigations deviations and change controls.
Participate in data reviews and trending related to aseptic or microbiological quality indicators (e.g. EM bioburden or utility monitoring) as needed.
Contribute to improvements in facility design procedures and behaviors that enhance aseptic performance and sterility assurance.
Participate in partner and regulatory audits provide required information and respond to findings as appropriate.
Operational Excellence
Actively participate in Lean Transformation and continuous improvement initiatives (e.g. SQDIP boards Kaizen events and Work Center Teams).
Use problem-solving and root-cause tools (5S Fishbone 5 Whys) to identify and implement improvements to aseptic performance and process control.
Additional Qualifications/Responsibilities
What we expect of you
We are all different yet we all use our unique contributions to serve patients. The professional we seek is a go getter with these qualifications.
Basic Qualifications:
Doctorate degree
Or
Masters degree and 2 years of operations or quality experience
Or
Bachelors degree and 4 years of operations or quality experience
Or
Associates degree and 8 years of operations or quality experience
Or
High school diploma / GED and 10 years of operations or quality experience
Preferred Qualifications:
10 years of biopharmaceutical or medical technology experience with increasing responsibility.
Bachelors or Masters degree in Microbiology Life Sciences or a related field.
Demonstrated expertise in aseptic processing isolator operations and media fill program management.
Experience supporting regulatory inspections and contamination control initiatives in a sterile manufacturing environment.
In-depth understanding of cGMPs aseptic technique and sterility assurance principles.
Familiarity with microbiological investigations environmental monitoring data interpretation and deviation management.
What you can expect from us
As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills experience and qualifications.
In addition to the base salary Amgen offers a Total Rewards Plan based on eligibility comprising of health and welfare plans for staff and eligible dependents financial plans with opportunities to save towards retirement or other goals work/life balance and career development opportunities that may include:
A comprehensive employee benefits package including a Retirement and Savings Plan with generous company contributions group medical dental and vision coverage life and disability insurance and flexible spending accounts
A discretionary annual bonus program or for field sales representatives a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models including remote and hybrid work arrangements where possible
Apply now and make a lasting impact with the Amgen team.
Salary Range
112977.00 USD - 139179.00 USD
Required Experience:
Unclear Seniority
Key Skills
- CCTV
- Federal Agencies
- Customer Service
- Clearance
- Facility
- Suspicious Activity
- Property Damage
- Public Safety
- Daily Operations
- Professional Development
- Access Control
- Communication
- General Public
- Procedures
- Powerpoint
About Company
VetJobs & Military Spouse Jobs works with our employer partners to source, screen, and move qualified talent to the desktops of the Hiring Managers. Application is a two-step process, so please be patient with the team. When you submit to a position on our site your information will ... View more
