Manufacturing Investigations Specialist I II or Senior
Manufacturing Investigations Specialist I II or Senior
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$ 59760 - 115390
1 Vacancy
Job Description
Our purpose is to bring hope to life by enabling lifechanging therapies for patients around the globe creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients lives by bringing new biopharmaceuticals to market.
The Manufacturing Investigations Specialist I II Senior position is primarily responsible for management and completion of site investigations. This position is an individual contributor role that works crossfunctionally to collect information used to assess impact identify root cause and mitigate recurrence through CAPAs. This position requires attention to detail organization multitasking and comfort interacting crossfunctionally with people who might be junior or senior to the incumbent. The successful candidate is able to work under the appropriate amount of direction based on level and possesses the ability to work on complex problems by analyzing procedures and data to create solutions.
ESSENTIAL JOB DUTIES & RESPONSIBILITIES
- Owns leads authors and drives site investigations to closure.
- Participates in or leads (based on level) deviation related meetings.
- Crossfunctional Triage meetings to gather facts/data upon event discovery.
- Investigation planning meetings to aligning internal review team and area subject matter experts on an agreed upon investigational path forward.
- Deviation and CAPA Review Board meetings to update leadership on status of investigations.
- Identifies Root Cause by utilizing common and advanced root cause analysis tools such as Control Charts Fishbone Diagrams 6Ms and 5 Whys.
- Authors Minor Major and Critical (based on level) investigation reports by utilizing robust technical writing skills to communicate moderate to complex technical issues.
- Serves as liaison between multiple teams including Manufacturing MSAT Engineering Quality Control Supply Chain and Quality Assurance to conduct and complete thorough deviation investigations.
- Ensures appropriate CAPAs are defined to address the identified root cause and suitable Effectiveness Checks are put into place to proactively ensure the effectiveness of the CAPA.
- Monitors assigned deviations to ensure on time closure.
- Maintains SOPs and other GMP documents as needed to support the program.
- Participates in the Quality Risk Management program when requested.
- May support regulatory inspections as a Subject Matter Expert (SME) for Deviations. (Sr. Specialist).
- May assist with on the floor support during manufacturing campaigns
- May be a mentor to peers for Root Cause analysis and Investigation writing. (Specialist II Sr. Specialist)
- This position is a delegate for other Investigation Specialists. Specialist may be a delegate for the Manager Investigations.
- Knowledge of API manufacturing processes.
- Knowledge and understanding of Root Cause Analysis processes in a regulated environment.
- Skill in effective verbal and written communications. Ability to respond quickly to complex inquiries from customers coworkers and supervisors regarding deviation details.
- Demonstrated conflict resolution skills in a crossfunctional setting with the ability to keep objectives on track.
- Proven technical writing skills within a cGMP manufacturing environment are strongly preferred
- Knowledge of and skill in using computer software and hardware applications. Proficiency with Microsoft applications including MS Word MS Excel and Teams (required) and with eQMS applications such as TrackWise (preferred).
- Demonstrated ability to work collaboratively to accomplish deadlines and objectives.
- Demonstrated ability to work in a fastpaced environment with the ability to manage multiple projects and objectives for ontime event closure.
- Ability to be proactive detailoriented and adapt to changing priorities.
TECHNICAL & LEADERSHIP SKILLS
- Experience with quality management system (MasterControl TrackWise etc. software preferred
- Experience interacting with clients in a Contract Development and Manufacturing Organization (CDMO) preferred
- Specialist II or Sr. Specialist may lead triage meetings; Sr. Specialist may lead Deviation Review Board.
- Strong knowledge of cGMP regulations and the ability to apply them to commercial manufacturing
EDUCATION & EXPERIENCE
- BS in scientific discipline such as Bioprocess Engineering Chemical Engineering Biochemistry or related discipline
- Equivalent education and experience may substitute for stated requirements
- Specialist I: Minimum 2 years experience in quality management systems conducting investigations and/or root cause analysis working in a regulated or GMP environment preferred
- Specialist II: Minimum 5 years experience in quality management systems conducting investigations and/or root cause analysis working in a regulated or GMP environment preferred
- Senior Specialist: Minimum 8 years experience in quality management systems conducting investigations and/or root cause analysis working in a regulated or GMP environment preferred
COMPENSATION
$59760$115390
Our culture at AGC Biologics is defined by the six core values: Knowledge Trust Quality Ingenuity Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work sidebyside with our clients and partners every step of the way. We provide worldclass development and manufacture of mammalian and microbialbased therapeutic proteins plasmid DNA (pDNA) messenger RNA (mRNA) viral vectors and genetically engineered cells. Our global network spans the U.S. Europe and Asia with cGMPcompliant facilities in Seattle Washington; Boulder and Longmont Colorado; Copenhagen Denmark; Heidelberg Germany; Milan Italy; and Chiba Japan. We currently employ more than 2500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients most complex challenges including specialization in fasttrack projects and rare diseases. AGC Biologics is the partner of choice. To learn more visit.Want to keep posted about our growth and learn more about our company Follow us on LinkedIn and give us a quick Like on Facebook!
AGC Biologics offers a highly competitive compensation package and a friendly collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age ancestry color family or medical care leave gender identity or expression genetic information marital status medical condition national origin physical or mental disability political affiliation protected veteran status race religion sexual orientation or any other characteristic protected by applicable laws regulations and ordinances.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
