Specialist/Sr. Specialist, Quality Assurance

Full Time Fremont CA Boehringer Ingelheim

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 quality assurance oversight of any area assigned where the business is 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. Demonstrates 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 ensuring documentation and investigations meet all requirements. 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.  Provides guidance and mentorship to junior staff regarding decision making processes and process expertise with high-level quality oversight to ensure compliance with cGMP’s, regulatory, industry, and corporate requirements.

 

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 executing QA 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 MFG, E&T, and/or QC 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.

Identifies, classifies and reports deviations, as appropriate and typically works on more complex Minor and/or Major deviations. 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 within area assigned and may escalate to senior management team based on severity of the issue.

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.

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 asked to become a certified Green-Belt and be 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 significantly involved in inspections by regulatory agencies.

Creates and establishes processes and procedures to ensure compliance and adherence to regulated QA activities for cGMP operations

Specialist Requirements:

  • Requires a Bachelor’s Degree from an accredited institution preferably in sciences plus minimum of three (3) years of experience working in the Quality related aspects of a life sciences or closely related industry.
  • In lieu of a Bachelor's Degree, a High School Diploma plus seven (7) years of experience working in the Quality related aspects of a life sciences or closely related industry will be considered.
  • Mentoring experience required.
  • Strong independent judgment and decision making abilities required.
  • Strong knowledge of relevant regulatory guidances.
  • Demonstrated problem-detection and problem-resolution skills required.
  • Strong conflict resolution and negotiation skills required.
  • Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.
  • Must possess excellent verbal and written communication skills; good interpersonal skills.
  • Capability to establish good relationships with others who have different values, cultural styles and perspectives.
  • Setting high and ambitious goals and standards for oneself and others, continuously raises the bar.

Sr. Specialist 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
  • Proven global problem-detection and problem-resolution skills required
  • Possesses strong conflict resolution and negotiation skills
  • Must be able to independently represent the department in a wide-assortment of situations
  • Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.
  • Must possess excellent verbal and written communication skills; good interpersonal skills.
  • Must have experience ensuring respectful interactions with individuals with diverse views or backgrounds.
  • Emerging leadership and mentoring experience required.  Must be able to indirectly lead others on the assigned floor / shift in the absence of the department head.
  • Ability to work independently.

Physical Demands / Surroundings – The duties of this position may require the incumbent to exert some physical effort.  Lifting requirements may vary dependent of the QA area assigned. Weight is typically no more than 25 pounds.  Work environment is dependent upon the area assigned.  For example, Manufacturing Operations QA requires full gowning and gloving certification, ILP will require inspection validation requirements are met, lab-based areas will require bench training and that laboratory protocols and dress code are adhered to. 

Visual Demands – Must be able to read and see clearly.  Employees assigned to ILP will be required to participate and have acceptable results from vision testing including color -blindness.

Temperaments/Mental Requirements – Frequently required to exercise judgement and make decisions.  Probable errors might cause moderately serious delays, confusion, and could affect company reputation/customer relations or expense to correct. 

Attendance / Schedule – Attendance requirements are based on BIFI general attendance policies. 

Eligibility Requirements:

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 boehringer-ingelheim.com and join us in our effort to make more health.

Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA Inc., Boehringer Ingelheim Animal Health Puerto Rico LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; citizenship status, marital, domestic partnership or civil union status; gender, gender identity or expression; affectional or sexual orientation; pregnancy, childbirth or related medical condition; physical or psychiatric disability; veteran or military status; domestic violence victim status; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by applicable federal, state or local law.

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