Sr. Quality Assurance Specialist

2 weeks ago

Hillsboro, United States BuildSubmarines.com Full time

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.

Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.

The Opportunity:

This position is part of Genentech's Pharma Technical-Hillsboro Innovative Therapies and cell therapy team, which is based in Hillsboro, Oregon. In this critical role, you will be part of a dedicated cross-functional team working on production start-up activities and tech transfer of new programs, helping to implement the quality approach for these exciting and novel technologies.

This position is located on-site in Hillsboro.

Shift flexibility and/ or rotation are necessary for this successful applicant. (Primarily weekend and swing shifts, as well as some day shifts) Responsible for ensuring commercial and clinical (IMP) products fulfill the specified requirements and they are released in legal compliance with the customer markets, regulatory filings, as well Roche quality requirements. Review and approve procedures, master batch records, and other QA-controlled documentation and associated change control.

Key Responsibilities: Responsible for lot disposition and release of commercial and clinical products according to the approved registration dossiers, ensuring internal standards are achieved and in compliance with local and international laws (e.g., Qualified Person/ Responsible Person). Create or revise quality documents. Provide Quality oversight for processes and procedures related to operations. Support and lead cross-functional projects and Quality initiatives. Identify and participate in the resolution of Quality risks and issues by fostering effective interdepartmental and cross-functional relations. Partner with functional areas to resolve product quality impacting investigations and own CAPA related to area of responsibility. Embody PT lean principles and methods while fostering a continuous improvement mindset.

Technical and Functional: Provide Quality Assurance oversight throughout the end-to-end production operations including Chain of Custody and Chain of Identity, assuring current GMP compliance. Participate and support internal and external audits. Serve as Subject Matter Expert to defend lot disposition practices, batch records, and reports Review and approve QA documentation to ensure GMP compliance to all relevant regulations. Ensure documentation supports a continuously compliant state at HIT and a continual state of readiness for their areas of responsibility for agency inspections. Responsible for monitoring and continuous improvement for relevant Quality key performance indicators Management of deviations & CAPA, ensuring robust, thorough and complete investigations (including root cause analysis, product quality impact, interim/mitigating/long term actions and documentation). Provide the appropriate oversight and support the implementation of the actions through appropriate records, timely resolution, action and closure of the quality system records, and their effectiveness. Assist in building a process for complaint management execution, including oversight of complaint intake, timely evaluation, trending and issue escalation.

Key Interfaces: Manufacturing, all Site functions, PTD, Affiliate Quality Assurance Management, Regulatory (PTR) Global Quality System and Quality Management, External Quality, Supplier Quality, partners, key suppliers and CMO

Who you Are: You hold a Bachelor's Degree (Pharmacy, Pharmaceutical, bioengineering, Chemistry or other relevant area preferred) 6 or more years of work experience in the pharmaceutical or related life science industry A minimum of at least 8 years of experience in Quality Assurance, Quality Control, Manufacturing, or equivalent experience Expert knowledge of Quality Assurance principles, practices and standards for the biopharmaceutical industry Demonstrate excellent problem-solving skills, tactical strategy, and diplomacy Able to independently resolve issues of high complexity and effectively lead cross-functional initiatives with broad scope. Influence extends beyond local area to network or groups outside of HIT.

Preferred Skills: Experience with Individualized Medicine (ATMP) Familiarity with computer systems and ability to quickly become familiar with new software (e.g., EDMS, LIMS, SAP) is highly desirable Expert knowledge of GMP(Good Manufacturing Practice) relevant to the pharmaceutical industry; knowledge of the local and international GMP regulations; knowledge of regulations related to ATMP (Adavance Therapy medicinal Products) is desirable.

Relocation benefits are approved for this position.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

  • Sr. Quality Assurance Specialist

    6 days ago

    Hillsboro, OR, 97104, Washington County, OR, United States Genentech, Inc. Full time

    A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.Genentech, a member of the Roche group and founder of the biotechnology...

  • Quality Assurance Inspector

    4 weeks ago

    Hillsboro, OR, United States DentalEZ Group Full time

    Take advantage of this great Quality Inspector opportunity with a top manufacturer offering an outstanding schedule, great benefits, and competitive pay! You will experience a company that truly cares about you by listening to your voice and providing hands-on training that will guarantee your long-term success. DENTALEZ Group is seeking a Quality...

  • Quality Assurance Representative

    4 weeks ago

    Hillsboro, United States FST Technical Services Full time

    Job DescriptionJob DescriptionFST Technical Services is your global partner in the Semiconductor and Microelectronics Industry! Come join an awesome team in an exciting, fast paced, and ever-growing industry! We are looking for Quality Assurance Representatives with experience in Welding/Piping to join our teams in the Hillsboro, OR area!  Oversee...

  • Quality Assurance Representative

    3 days ago

    Hillsboro, United States FST Technical Services Full time

    Job DescriptionJob DescriptionFST Technical Services is your global partner in the Semiconductor and Microelectronics Industry! Come join an awesome team in an exciting, fast paced, and ever-growing industry! We are looking for Quality Assurance Representatives with experience in Welding/Piping to join our teams in the Hillsboro, OR area! Oversee...

  • Sr. Quality

    4 weeks ago

    Hillsboro, United States Thermo Fisher Scientific Full time

    Job Description Job Description At Thermo Fisher Scientific team, you'll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and...

  • Quality Control

    1 week ago

    Hillsboro, United States FST Technical Services Full time

    Job DescriptionJob DescriptionMission Critical Assured.FST Technical Services was founded in 1984 to serve the needs of the growing, worldwide Semiconductor/Microelectronics and Life Sciences industries. FST Technical Services is seeking entry level Quality Assurance/Analytical Test Technicians.  This is a great opportunity for candidates that want to...

  • Quality Control

    1 week ago

    Hillsboro, United States FST Technical Services Full time

    Job DescriptionJob DescriptionMission Critical Assured.FST Technical Services was founded in 1984 to serve the needs of the growing, worldwide Semiconductor/Microelectronics and Life Sciences industries. FST Technical Services is seeking entry level Quality Assurance/Analytical Test Technicians.  This is a great opportunity for candidates that want to...

  • Quality Inspector

    4 weeks ago

    Hillsboro, United States DentalEZ Group Full time

    Take advantage of this great Quality Inspector opportunity with a top manufacturer offering an outstanding schedule, great benefits, and competitive pay! You will experience a company that truly cares about you by listening to your voice and providing hands-on training that will guarantee your long-term success. DENTALEZ Group is seeking a Quality Inspector...

  • Quality Inspector

    4 weeks ago

    Hillsboro, United States DentalEZ Group Full time

    Take advantage of this great Quality Inspector opportunity with a top manufacturer offering an outstanding schedule, great benefits, and competitive pay! You will experience a company that truly cares about you by listening to your voice and providing hands-on training that will guarantee your long-term success. DENTALEZ Group is seeking a Quality Inspector...

  • 5099 Quality Engineer ll

    3 weeks ago

    Hillsboro, United States Harvest Technical Services Full time

    Job DescriptionJob Description *Onsite in Hillsboro, OR Main Purpose of the Position: Provide technical review and approve validation deliverables ensuring proper study design and execution. Maintain the compliance status of the assigned validation areas at a state of inspection readiness. Working with multiple functions, lead solution of validation issues...

  • Quality Inspector

    4 weeks ago

    Hillsboro, OR, United States DentalEZ Group Full time

    Take advantage of this great Quality Inspector opportunity with a top manufacturer offering an outstanding schedule, great benefits, and competitive pay! You will experience a company that truly cares about you by listening to your voice and providing hands-on training that will guarantee your long-term success. DENTALEZ Group is seeking a Quality...

  • Operations Support Specialist

    4 weeks ago

    Hillsboro, United States First Tech Federal Credit Union Full time

    ** Operations Support Specialist** **Job Category****:** Contributor **Requisition Number****:** OPERA007071 Showing 1 location **Job Details** **Description** The Operations team is looking for a new Operations Support Specialist to join the team. In this role, you will administer the incentive compensation plans company-wide and will collaborate with other...

  • Construction Document Control Specialist

    4 weeks ago

    Hillsboro, United States JLM Strategic Talent Partners Full time

    WHO IS JLM STRATEGIC TALENT PARTNERS & WHAT IS OUR ROLE We partner with National & International prime contractors to provide them with qualified talent they can trust. We accomplish this by sourcing & vetting high level career seeking candidates in the industry and match them with our partners current open roles. Our objective is to help our general...

  • Procurement Specialist

    5 days ago

    Hillsboro, United States WorkSource Oregon Full time

    "** Please note, this is not a direct position with WorkSource Oregon. WorkSource Oregon is conducting this recruitment on behalf of the employer**" This staffing agency loves building long-term relationships by providing the tools and skills people need to succeed in any role. They propel their culture forward by working to build more equitable workplaces...

  • Behavior Specialist

    2 weeks ago

    Hillsboro, United States Albertina Kerr Centers Full time

    Albertina Kerr empowers people with intellectual and developmental disabilities, mental health challenges and other social barriers to lead self-determined lives and reach their full potential!As a Behavior Specialist, you'll be responsible for implementing and monitoring systems that support people who perform challenging behaviors. You'll facilitate...

  • Procurement Specialist

    3 weeks ago

    Hillsboro, United States WorkSource Oregon Full time

    "** Please note, this is not a direct position with WorkSource Oregon. WorkSource Oregon is conducting this recruitment on behalf of the employer**"This staffing agency loves building long-term relationships by providing the tools and skills people need to succeed in any role. They propel their culture forward by working to build more equitable workplaces...

  • Procurement Specialist

    3 weeks ago

    Hillsboro, United States WorkSource Oregon Full time

    "** Please note, this is not a direct position with WorkSource Oregon. WorkSource Oregon is conducting this recruitment on behalf of the employer**"This staffing agency loves building long-term relationships by providing the tools and skills people need to succeed in any role. They propel their culture forward by working to build more equitable workplaces...

  • Procurement Specialist

    2 weeks ago

    Hillsboro, United States WorkSource Oregon Full time

    "** Please note, this is not a direct position with WorkSource Oregon. WorkSource Oregon is conducting this recruitment on behalf of the employer**"This staffing agency loves building long-term relationships by providing the tools and skills people need to succeed in any role. They propel their culture forward by working to build more equitable workplaces...

  • Technical Support Specialist

    4 weeks ago

    Hillsboro, United States Consultant Specialists, Inc. (CSI) Full time

    Onsite -1 day remote after trainingTop 3 qualifications you are looking for on a resume (technologies worked with, skill sets, etc.)1. Strong Technical Background working with various technologies, software, and support structures.2. Troubleshooting skills. Experience working on issues that are complex and being able to isolate issues that haven't been seen...

  • Technical Support Specialist

    1 month ago

    Hillsboro, United States Consultant Specialists, Inc. (CSI) Full time

    Onsite -1 day remote after trainingTop 3 qualifications you are looking for on a resume (technologies worked with, skill sets, etc.)1. Strong Technical Background working with various technologies, software, and support structures.2. Troubleshooting skills. Experience working on issues that are complex and being able to isolate issues that haven't been seen...