Senior Associate Quality Assurance Thousand Oaks CA
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Job Location:
Thousand Oaks, CA - USA
Monthly Salary:
$ 111052 - 111052
Posted on:
15 hours ago
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.
Lets do this! Lets change the world!
The Sr. Associate QA will be a member of the Amgen Thousand Oaks Clinical Final Drug Product QA team. Must have experience with GMP processes and documentation. Without that fundamental skillset the training for document review tasks label approval and packaging inspection will have no foundation. The Sr. Associate QA must be able to methodically and meticulously inspect printed materials for print quality defects clinical product components (e.g. syringes and vials) for physical defects and batch record documentation for accuracy and completeness. Must be able to work in a team with shifting priorities and shifting responsibilities such that the team members must be confident verbal communicators able to discuss responsibilities divide them reassess them and potentially reassign them throughout the day or week. The Sr. Associate QA may also represent Quality in cross functional teams in the execution of projects necessary to achieve departmental operational excellence goals and will work in a team matrix environment.
Responsibilities include:
Internal Quality Assurance support for Final Drug Product Packaging
Review and approval of printed clinical labels
Finished clinical pack inspection
Expiration date calculation
Electronic batch record review
GMP Document (SOPs/FORMs) revision review/approval
Review and approval of electronic Maintenance documentation Work Order/Job Plans.
Quality support and approval of minor deviations
Electronic Batch Record (MES) documentation revisions and approval.
Quality support and approval of minor deviations
Internal Quality Assurance support for creation and revision of GMP procedures including document review approval and archival
Generation and compilation of quality data and reports (e.g. lot track/trace deviations). Individual will also assist with procedure reviews and initiation of deviation reports.
Alerts management of significant quality compliance supply and safety risks
Participates as a QA team member process during regulatory inspections third party audits and internal audits
The successful candidate will have experience working in multiple GMP databases
What we expect of you
We are all different yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.
The Sr. Associate QA will be a member of the Amgen Thousand Oaks Clinical Final Drug Product QA team. Must have experience with GMP processes and documentation. Without that fundamental skillset the training for document review tasks label approval and packaging inspection will have no foundation. The Sr. Associate QA must be able to methodically and meticulously inspect printed materials for print quality defects clinical product components (e.g. syringes and vials) for physical defects and batch record documentation for accuracy and completeness. Must be able to work in a team with shifting priorities and shifting responsibilities such that the team members must be confident verbal communicators able to discuss responsibilities divide them reassess them and potentially reassign them throughout the day or week. The Sr. Associate QA may also represent Quality in cross functional teams in the execution of projects necessary to achieve departmental operational excellence goals and will work in a team matrix environment.
Responsibilities include:
Internal Quality Assurance support for Final Drug Product Packaging
Review and approval of printed clinical labels
Finished clinical pack inspection
Expiration date calculation
Electronic batch record review
GMP Document (SOPs/FORMs) revision review/approval
Review and approval of electronic Maintenance documentation Work Order/Job Plans.
Quality support and approval of minor deviations
Electronic Batch Record (MES) documentation revisions and approval.
Quality support and approval of minor deviations
Internal Quality Assurance support for creation and revision of GMP procedures including document review approval and archival
Generation and compilation of quality data and reports (e.g. lot track/trace deviations). Individual will also assist with procedure reviews and initiation of deviation reports.
Alerts management of significant quality compliance supply and safety risks
Participates as a QA team member process during regulatory inspections third party audits and internal audits
The successful candidate will have experience working in multiple GMP databases
What we expect of you
We are all different yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.
Additional Qualifications/Responsibilities
What we expect of you
We are all different yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.
Basic Qualifications:
Masters Degree OR
Bachelors Degree & 6 months of cGMP experience OR
Associates degree & 2 years of cGMP experience OR
High school diploma/GED & 4 years of cGMP experience
Preferred Qualifications:
Quality and Manufacturing experience in biotech or Pharmaceutical industry
Bachelors Degree in Science field
Familiarity with basic project management tools
Ability to successfully manage workload to timelines
Previous experience with quality system transactions (SAP SM-LIMS Trackwise VeevaVault)
Demonstrated experience creating deviation technical assessments or equivalent
Demonstrated ability to perform GMP operations including following detailed SOPs maintaining training and adhering to good documentation practices.
Proficient with database use including data input archival and query retrieval
Strong attention to detail and high degree of accuracy in task execution and GMP documentation
Highly effective verbal and written communication skills strong interpersonal skills
Ability to complete tasks autonomously provide updates to area manager and identify potential issues
What you can expect of 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.
Salary Range
82081.95USD -111052.05 USD
Required Experience:
Senior IC
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
