Specialist, QA Disposition
Expiry Date :
Sat, 19 Jun 2021 23:59:59 GMT
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Boehringer Ingelheim Fremont is the rapidly growing US arm of Boehringer Ingelheims Biologics Business Unit. We are a fully integrated biologics operation with over 500 scientist and specialists, covering cutting edge early- to late stage CMC development, clinical and commercial drug substance and drug product manufacturing, medical device assembly for combination products and packaging operations.
We are continuing our rapid growth, investing over $200m into the expansion of our capacity and capabilities, and creating approximately 200 new jobs.
Driving this growth is an exciting pipeline of multiple Boehringer Ingelheim novel biologic entities (NBEs) and biosimilars, as well as, a growing diverse portfolio of therapeutics we develop and manufacture for other leading pharma and biotech companies. This includes multiple commercial product launches planned over the next couple of years, for which we can tap into Boehringer Ingelheims unique experience of having brought 30+ biologics to market globally.
Leveraging our diverse talent pool, we are also driving technology and innovation globally, through major investment and collaborations into next generation manufacturing platforms and technologies, which may change how biologics will be made in the future.
Whether we work on our own products, help partners to bring their products to market or innovate new technologies and approaches – Everything we do, we do to help patients!#LI-MS1 *I-SF1 #
The person in this position is responsible for performing batch coordination, compilation, and disposition for internal BI products and client products. This role serves as a disposition subject matter expert for disposition topics and is responsible for executing site priorities, maintaining disposition processes, and supporting process improvements to achieve company goals and department objectives.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies’ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim’s high regard for our employees.
DUTIES & RESPONSIBILITIES:
* Performs assigned batch disposition activities (CoA, CofC, lot genealogy, deviation and Change Control queries, etc.) in alignment with cGMP and global BI requirements for clinical and commercial release.
* Identifies deviations throughout Disposition operations; records and reports issues to appropriate parties; recommends corrective action and follows up to ensure timely resolution.
* Makes recommendations on batch disposition based on overall quality assessment of the batch. Must be able to present rationales and defend disposition decisions to Sr. Disposition Manager.
* Provides batch metrics as applicable to defined processes and site goals.
* Manages deviations, CAPAs, Change Controls as the QA Contact when needed/assigned.
* Identifies and supports local process improvements within the Quality Assurance organization.
* Associate’s degree from an accredited institution plus five (5) years of Quality experience or equivalent in a cGMP pharmaceutical manufacturing environment with positions of increasing responsibility; Or
* Bachelors degree from an accredited institution in Science (Chemistry, Biochemistry, Microbiology) from an accredited institution required with three (3) years of relevant experience.
* Strong experience in Quality systems such as Batch Release, Deviations, Auditing or Change Control.
* Experience and knowledge in biologics or combination product manufacturing, quality oversight, and release of clinical or commercial products.
* Ability to compile and review large amounts of data, documents, and procedures with strong attention to detail and to make accurate and sound decisions on batch releasability.
* Expertise in Standard Operating Procedures, Good Manufacturing Practices, Food and Drug Administration, and other national and international regulatory requirements related to quality testing in a clinical and commercial environment.
* Auditing (internal/supplier) experience in a cGMP environment.
* Demonstrated influencing, relationship building, and effective facilitation skills.
* Good communication skills with the ability to build strong working relationships with management and clients.
* Demonstrated ability to execute against the strategic and tactical objectives provided by leadership both within Quality and outside of the function.
* Overall understanding of Quality Assurance specifications.
* Ability to interpret and relate Quality standards for implementation and review to functional areas.
* Ability to work effectively on problems of diverse scope, with analysis/evaluation of data.
* High level of personal motivation and initiative, demonstrated innovation, and ability to work independently on projects.
* Strong decision-making skills.
* Attention to detail, safety, quality, and customer requirements.
* Proficiency with MS Office products (specifically Word, Outlook, PowerPoint and Excel).
* Experience in SAP, OpsLIMs and Trackwise a plus.
* Must be legally authorized to work in the United States without restriction.
* Must be willing to take a drug test and post-offer physical (if required).
* Must be 18 years of age or older.
WHO WE ARE:
At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance.We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture.Learning and development for all employees is key because your growth is our growth.
Want to learn more? Visit [/http% and join us in our effort to make more health.
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a persons actual or perceived race; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.