FremontRecruiter Since 2001
the smart solution for Fremont jobs

Senior Specialist, Quality Assurance

Company: Boehringer Ingelheim
Location: Fremont
Posted on: April 10, 2021

Job Description:

Description:

Boehringer Ingelheim Fremont is the rapidly growing US arm of Boehringer Ingelheim's 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 Ingelheim's 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 PDN1

Description\:

Works independently to provide leadership and oversight to junior QA team members as they provide QA oversight of any area of the business responsible for adhering to current Good Manufacturing Practices (cGMPs) including critical utilities, (e.g. WFI, Steam, Automation, equipment, HVAC, etc.), warehouse, manufacturing processes, inspection, labeling and packaging, batch record review, batch disposition, new product introduction/product transfer, external quality and laboratories. Utilizing a wealth of previous experience, provides a high level of independent judgment and discretion in the timely identification, investigation and resolution of events impacting the Quality of products and processes. Quality oversight responsibilities include ensuring adherence to SOPs and requirements, proper change control, corrective action and preventive action plans (CAPA)/Deviation management, impact assessments for changes to equipment and processes, risk management, and to ensure documentation and investigations meet BIFI and regulatory standards. With autonomy and authority, makes difficult decisions with little time for deliberation which may have a direct impact on active manufacturing operations, the release of equipment, systems, or areas. Responsible for mentoring, coaching, may act as a delegate to sign official documentation in the place of management, and makes difficult decisions with little time for deliberation that can have a direct impact on active manufacturing operations, the release of equipment or area, or product release. Implements continuous improvement efforts as it relates to QA activities. Indirectly leads others within the QA Team under the leadership of the area head. Fosters quality collaboration among the site and QA staff.

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\:


  • Responsible for both executing the tactical operations and overseeing junior team members as they assess, evaluate, and review operations on the floor (as defined above) against cGMPs to assure real-time observation of activities, issue identification/ resolution including proper and timely documentation. Provides guidance to all GMP areas (i.e. MFG, E&T, QC, etc.) to ensure compliance with all applicable regulations and assists in resolution of issues identified. Information must be pro-actively shared across QA and the business including the on-going training of junior team members.
  • Independently serves as QA representative in decision making and conflict resolution with junior team members as needed in the absence of the department head.
  • Identifies, classifies and reports deviations, as appropriate and typically works on complex Major deviations and/or complaints. Oversees execution of remediation/CAPA activities required to continue production or move a process to the next milestone. Works closely with others to determine root cause and potential preventative/corrective actions. Ensures support for the timely closure of investigations.
  • Authorized to suspend any operation when the situation warrants. Provides guidance and control directives regarding remediation activities required to continue production. Is required to resolve critical issues utilizing independent judgement and decision making as a senior level of the department. May serve as the final decision-maker in situations requiring the Sr. QA Specialist to utilize the input of others to make a final compliance determination. .
  • May also be required to communicate with clients, external vendors, external services to resolve investigations as warranted to ensure compliance to regulations and local procedures.
  • Responsible for providing quality oversight to the change management system for complex Minor and/or Major classified Change Controls. This includes providing plan creation oversight, verifying that changes adhere to local SOPs and regulatory compliance and ensuring communication/escalation of potential issues of broader impact to the business. Sought after by junior team members for guidance in the quality oversight of changes within the Quality Management System including approriate stakeholders reviews are completed such as Regulatory, Client, Area Managers, etc.
  • Performs independent technical review of documentation during and post-execution of cGMP activities. Has authority to sign off/qualify/train junior staff on QA Operation responsibilities. Ensures all specifications are met and that applicable requirements are completed and acceptable. Ensures all issues/documentation associated with each process in assigned area have been resolved and Approved prior to release to the next step and are compliant with cGMPs and SOPs and current manufacturing regulations and site procedures. Analyzes and reports findings to appropriate departments.
  • Works closely with others in the assigned area to recognize opportunities for improvement and drive change through the use of BIFI's Quality Systems. May be a certified Green-Belt and assigned to lead process improvement initiatives via the BPE program. May also attend, as a QA project team member to provide QA guidance and oversight to such improvements.
  • Will serve as Subject Matter Expert for internal or external matters. Participates in inspection readiness activities and is significantly involved in inspections by regulatory agencies.
  • Models effective and constructive communication behaviors and interactions with technical departments, junior team members and senior business leaders, both orally and in writing; maintain acceptable proficiency in technical and non-technical (e.g. interpersonal) skills.
  • Is proficient in technical and non-technical (e.g. interpersonal) skills to ensure the continued success of the department and quality of oversight provided to the business.
  • Creates and establishes processes and procedures to ensure compliance and adherence to regulated QA activities for cGMP operations.
  • Mentors, trains and coaches new personnel as required and supports the development and implementation of training programs. Available to act as a resource for colleagues with less experience regardless of level. Will provide input on the performance of junior team members to the department head as part of the performance management process.
    Requirements\:


    • Requires a Bachelor's or higher degree from an accredited institution preferably in sciences.
    • Requires a minimum of five (5) years of experience working in the Quality aspects of a life sciences or closely related industry.
    • Requires a minimum of one (1) year of experience managing projects and priorities within complex matrix organizations.
    • Must have demonstrated ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function.
    • Strong independent judgment and decision making abilities required.
    • Experience leading people and/or projects with history of achieving results and outstanding outcomes.
    • Advanced knowledge of relevant regulations and guidances required in order to act as a resource for colleagues.
    • Proven project-management skills required. Must be able to manage multiple projects against given time-lines.
    • Demonstrated hard-working and productive work ethic in an ambiguous environment strongly preferred.
    • Independent decision making capability and ability to think conceptually and understand impact of decisions critical..... click apply for full job details

Keywords: Boehringer Ingelheim, Fremont , Senior Specialist, Quality Assurance, Other , Fremont, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


24 OR 26 FT BOX TRUCK INDEPENDENT CONTRACTORS
Description: Job Description: br br 24 OR 26 FT BOX TRUCK INDEPENDENT CONTRACTORS Woodland br br Updike DL is looking for independent owner-operators that are experienced in home delivery and assembly of (more...)
Company: Updike Distribution Logistics
Location: Woodland
Posted on: 04/18/2021

Lyft CA Driver - Guaranteed Earnings and Benefits
Description: Job DescriptionDriving with Lyft in California means you get guaranteed earnings, new benefits, and the flexibility to drive when and where you want. Apply to drive with Lyft in California and start earning (more...)
Company: Lyft
Location: Woodland
Posted on: 04/18/2021

Grocery Shopper - Hiring Immediately
Description: Job Description Shipt is a membership-based marketplace that helps people get the things they need, like fresh produce and household essentials, from stores they trust. Help people save time and have (more...)
Company: Shipt
Location: Woodland
Posted on: 04/18/2021


Hair Stylist - Camellia Center
Description: StylistAt Great Clips, we know that stylists like you are most happy when they're cutting hair, so at a Great Clips salon, that's exactly what you get to do Want to be the best stylist
Company: Great Clips
Location: West Sacramento
Posted on: 04/18/2021

Order Entry Clerk
Description: General Summary:Collect orders from individuals or large clients and import orders to be submitted and processed by warehouse workers to get materials moving to the customer. Responsible for taking down (more...)
Company: Hassan & Sons Inc
Location: Woodland
Posted on: 04/18/2021

Sales Account Executive
Description: AT T is leading the way to the future for customers, businesses and the industry. We're developing new technologies to make it easier for our customers to stay connected to their world. Together, weve (more...)
Company: AT&T
Location: West Sacramento
Posted on: 04/18/2021

Nanny Needed For 1 Child In West Sacramento.
Description: Our 10 month year old is a total ham loves to be read to and played with. He
Company: Care.com
Location: West Sacramento
Posted on: 04/18/2021

Customer Service/Sales
Description: Job Description Position Purpose:Customer Service/Sales associates provide fast, friendly service by actively seeking out customers to assess their needs and provide assistance. These associates learn
Company: The Home Depot
Location: Woodland
Posted on: 04/18/2021

Urgent Hiring - Shipt Shopper
Description: Job Description Shipt is a membership-based marketplace that helps people get the things they need, like fresh produce and household essentials, from stores they trust. Help people save time and have (more...)
Company: Shipt
Location: Woodland
Posted on: 04/18/2021

Program Aide
Description: Overview: Dignity Health Woodland Memorial Hospital is Yolo County's largest health care provider, serving the community since 1905. Woodland Memorial Hospital is a 108-bed acute care facility offering (more...)
Company: Woodland Healthcare
Location: Woodland
Posted on: 04/18/2021

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Fremont RSS job feeds