Current jobs related to Specialist Quality Assurance - Thousand Oaks - Amgen

  • Quality Assurance Specialist

    4 weeks ago

    Thousand Oaks, California, United States Collabera Full time

    Job Title: Quality Assurance SpecialistAbout the Role:We are seeking a Quality Assurance Specialist to join our team at Collabera. The ideal candidate will have a minimum of two years of experience in a GMP or GLP environment, with strong skills in pipetting, documentation, and aseptic techniques.Responsibilities:Perform routine laboratory proceduresConduct...

  • Quality Assurance Specialist

    4 weeks ago

    Thousand Oaks, California, United States Futran Tech Solutions Pvt. Ltd. Full time

    Job Summary:We are seeking a skilled Quality Assurance Specialist to support our shop floor quality activities at our Aerospace facility. The ideal candidate will have good experience and a mindset for paperwork, quality issues reporting, and working with internal and supplier teams to resolve issues timely. Key responsibilities include inspecting parts,...

  • Senior Associate Quality Assurance Specialist

    4 weeks ago

    Thousand Oaks, California, United States BioSpace, Inc. Full time

    Job SummaryWe are seeking a highly skilled Senior Associate Quality Assurance Specialist to provide oversight for distribution and supply chain operations for commercial and clinical biopharmaceutical products.Key ResponsibilitiesEnsure compliance to GMP regulations for area operations and associated processes, including warehousing and distribution and...

  • Quality Assurance Specialist

    1 month ago

    Thousand Oaks, California, United States Beacon Hill Pharma Full time

    Job SummaryBeacon Hill Pharma is seeking a highly skilled Quality Assurance Associate to provide operational support to our clinical drug product packaging and labeling team. The ideal candidate will have experience in quality assurance or manufacturing in the pharmaceutical industry, with a strong understanding of GMP processes and documentation.Key...

  • Quality Assurance Manager

    4 weeks ago

    Thousand Oaks, California, United States VetJobs Full time

    Quality Assurance Manager Job DescriptionAt VetJobs, we're committed to serving patients living with serious illnesses. As a Quality Assurance Manager, you'll play a critical role in ensuring the quality of our products and services.Key Responsibilities:Lead and direct Incoming Quality Assurance staff, including managing their performance and supporting...

  • Quality Assurance Manager

    4 weeks ago

    Thousand Oaks, California, United States National Guard Employment Network Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Manager to join our team at National Guard Employment Network. As a key member of our Building 31 Plant QA team, you will provide Quality oversight for the GMP Receiving function, ensuring the review and release of incoming product and raw material shipments.Key ResponsibilitiesLead and direct...

  • Quality Assurance Specialist

    6 days ago

    Thousand Oaks, United States Randstad Full time

    At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We...

  • Quality Assurance Specialist

    5 days ago

    Thousand Oaks, United States Randstad Full time

    At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We...

  • Quality Assurance Specialist

    6 days ago

    thousand oaks, United States Randstad Full time

    At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We...

  • Senior Quality Assurance Specialist

    4 weeks ago

    Oaks, United States Chelsoft Solutions Co Full time

    Job OverviewWe are seeking a skilled Quality Assurance Specialist to join our Portfolio Management Engineering team. The ideal candidate will have a strong understanding of portfolio management processes and applications, as well as experience in testing backend services and front-end UIs.Key Responsibilities:Perform quality assurance testing for portfolio...

  • MCS Associate Quality Assurance Specialist

    1 month ago

    Thousand Oaks, California, United States Aditi Consulting Full time

    Job Summary:This role will provide operational quality assurance support to a clinical drug product packaging and labeling team. The successful candidate will be responsible for reviewing and approving printed clinical labels, inspecting finished clinical packs, calculating expiration dates, and reviewing batch records. Additionally, they will assist with...

  • MCS Associate Quality Assurance Specialist

    1 month ago

    Thousand Oaks, California, United States Aequor Technologies Full time

    Job Summary: Aequor Technologies is seeking a highly skilled MCS Associate Quality Assurance to provide operational QA support of a clinical drug product packaging and labeling team. Key Responsibilities: Review and approve printed clinical labels, inspect finished clinical packs, calculate expiration dates, and review batch records. Generate and compile...

  • Manufacturing Process Technician

    4 weeks ago

    Thousand Oaks, California, United States Quality Consulting Group Inc Full time

    Quality Consulting Group Inc is seeking a skilled Manufacturing Process Technician to support our team in ensuring the highest quality standards in our manufacturing operations.In this role, you will be responsible for providing facility and equipment cleaning and sanitation services in support of FDA-regulated manufacturing areas.Key...

  • Quality Assurance Associate

    2 weeks ago

    thousand oaks, United States Beacon Hill Full time

    This position will provide operational QA support of a clinical drug product packaging and labeling team. Primary responsibilities will include review and approval of printed clinical labels, finished clinical pack inspection, expiration date calculation and batch record review. Secondary responsibilities will include generation and compilation of quality...

  • Quality Assurance Associate

    4 weeks ago

    thousand oaks, United States Beacon Hill Full time

    This position will provide operational QA support of a clinical drug product packaging and labeling team. Primary responsibilities will include review and approval of printed clinical labels, finished clinical pack inspection, expiration date calculation and batch record review. Secondary responsibilities will include generation and compilation of quality...

  • Quality Assurance Associate

    1 month ago

    Thousand Oaks, United States Beacon Hill Full time

    This position will provide operational QA support of a clinical drug product packaging and labeling team. Primary responsibilities will include review and approval of printed clinical labels, finished clinical pack inspection, expiration date calculation and batch record review. Secondary responsibilities will include generation and compilation of quality...

  • Quality Assurance Associate

    1 month ago

    Thousand Oaks, United States Beacon Hill Full time

    This position will provide operational QA support of a clinical drug product packaging and labeling team. Primary responsibilities will include review and approval of printed clinical labels, finished clinical pack inspection, expiration date calculation and batch record review. Secondary responsibilities will include generation and compilation of quality...

  • Quality Assurance Associate

    1 month ago

    Thousand Oaks, United States Beacon Hill Pharma Full time

    Job DescriptionJob DescriptionThis position will provide operational QA support of a clinical drug product packaging and labeling team. Primary responsibilities will include review and approval of printed clinical labels, finished clinical pack inspection, expiration date calculation and batch record review. Secondary responsibilities will include generation...

  • Quality Assurance Associate

    4 weeks ago

    thousand oaks, United States Aequor Full time

    MCS Associate Quality Assurance (Onsite Job)Location: Thousand Oaks, CATerms: Contract W2Duration : 18 Months Contract (Will Get Extended for Long)Description:100% Thousand Oaks Schedule will be 7am -4pm, Flexibility to potentially work swing shift 18 months possible extension. Ideal Candidate: Looking for candidate committed to working the duration of the...

  • Quality Assurance Associate

    4 weeks ago

    thousand oaks, United States Aequor Full time

    MCS Associate Quality Assurance (Onsite Job)Location: Thousand Oaks, CATerms: Contract W2Duration : 18 Months Contract (Will Get Extended for Long)Description:100% Thousand Oaks Schedule will be 7am -4pm, Flexibility to potentially work swing shift 18 months possible extension. Ideal Candidate: Looking for candidate committed to working the duration of the...

Specialist Quality Assurance

2 months ago

Thousand Oaks, United States Amgen Full time

Join Amgens Mission of Serving Patients

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.

Quality Assurance Specialist

What you will do

Lets do this Lets change the world

The Quality Management Systems (QMS) Specialist supports operations at the Amgen, Thousand Oaks site by providing site level oversight for one or more Quality Processes. The oversight will include SME level guidance for process end users, performance monitoring and management of the process(es) at the site level, end user voice of customer engagement, as well as interaction with the Corporate Quality Global Process Owner (GPO) to recommend process improvements and to facilitate global alignment and improvement implementations. The QMS Specialist may support one or more of the following processes depending on fit and experience, Document Management, Recalls, Disposition, Inspection Readiness, Learning & Performance, Risk Management, Management Review, Equipment Qualification, Calibration and Maintenance, and various Process Development processes.

Responsibilities:

Ensure QMS processes are appropriately designed, implemented and managed across the ATO site to ensure they are fit for purpose for effective phase appropriate practices in Process Development, Clinical and Commercial functions.

Ensure appropriate escalation of key QMS risks and accomplishments to senior management, through Management Review.

Actively participate and provide leadership on Amgens global QMS networks, learning from peer sites and influencing Amgens overall QMS strategy.

Translate external regulations into understandable and implementable processes at ATO

Based on execution performance, propose and implement Continuous Improvement and Productivity initiatives, programs and projects.

Represent Quality on cross functional teams in the execution of projects necessary to achieve departmental operational excellence goals and will work in a team matrix environment.

Review and approve controlled documents, including Standard Operating Procedures, and reports

Participate in Amgen internal/external audits and inspections, potentially interacting directly with regulatory and/or third party auditors.

Author and own (potentially) cGMP documents and reports

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 individual with these qualifications.

Basic Qualifications:

Doctorate degree OR

Masters degree and 2 years of quality systems experience OR

Bachelors degree and 4 years of quality systems experience OR

Associates degree and 8 years of quality systems experience OR

High school diploma / GED and 10 years of quality systems experience

Preferred Qualifications:

Highly effective verbal and written communication skills with strong interpersonal skills

Strong level of analytical skills to evaluate and interpret information to arrive at logical and quality-minded conclusions balanced with a willingness to take informed and appropriate risks.

Extensive knowledge of Quality Assurance functions and practices across a broad range of manufacturing and supply chain processes

Strong leadership capabilities and proven experience applying GMP requirements in an operational setting

Ability to effectively present information to all levels of the organization with appropriate messaging and effective focus on desired outcomes.

Demonstrated ability with project management, initiating and leading cross-functional teams, leading and managing change

Previous experience with quality system transactions (SAP, LIMS, Trackwise, Veeva)

Proficiency with database use, including data input, archival, and query retrieval

Direct experience driving process improvements. Working knowledge of Lean and Six Sigma methodologies a plus

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.

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

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.