|Location:||Fremont, CA (94538)|
|Job Type:||Full Time|
|Posted:||5 days ago|
Works independently to provide analytical testing support for release, stability, validation, and in-process samples while adhering to current Good Manufacturing Practices (cGMPs). 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. Responsibilities include conducting analytical testing per approved SOPs and methods, analyzing and reporting data, and maintaining lab equipment. Must be able to identify and report aberrant results to manager and conduct or assist in laboratory investigations. Must be able to author analytical protocols reports for method transfer or validation. Individual must understand regulatory guidelines for analytical method validation and translate guidelines into effective experimental designs. Must be able to communicate experimental design to other analysts that would participate. Must be able to effectively multi-task with respect to running multiple individual assays, writing protocols/reports, reviewing data.
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, and test results. 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 overseeing junior team members executing testing. Under no supervision leads/participates in analytical laboratory investigations, solve technical problems such as invalid assays or equipment breakdown, and identify aberrant results to management. Follows well-defined and established procedures and best practices. Reviews and approves QC test results in a timely manner.
Must be able to pro-actively identify issues to prevent missed timelines.
Provides guidance to MFG, E&T, and/or QA to ensure compliance with all applicable regulations and assists in resolution of issues identified. Information must be pro-actively shared across QC and the business including the on-going training of junior team members. Must be able to interact effectively with other groups to provide support, review of data, sharing of information/scheduling.
Identifies and resolves critical issues (including deviations, investigations, OOS, etc.), as appropriate and typically works on more complex Minor and/or Major issues. 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 inhibit the release of test results when the situation warrants. Provides guidance and control directives regarding remediation activities required to continue testing.
Highly productive, attention to detail, ability to manage own time and time of junior staff to prioritize tasks independently and meet timelines. Maintain laboratory to a high quality and compliance standard. Provide supervisory role to ensure testing result is released on time in Manager's absence.
Responsible for method validation and method transfer activities. Must understand ICH guidelines and translate requirements into effective experimental designs. Must be able to manage completion of entire method validation including the coordination of approvals for protocols/report, completion of experiments by other junior analysts, incorporation of comments into protocols/report, and overall completion to agreed timelines and ensuring communication/escalation of potential issues of broader impact to the business. Actively support cross functional teams and share information, able to initiate and effectively conduct cross-functional meetings as appropriate, with colleagues.
Effectively communicate with supervisors, colleagues and/or managers in other departments and sites.
Performs independent technical review of documentation during and post-execution of cGMP activities. Has authority to sign off/qualify/train junior staff on QC responsibilities. Ensures all specifications, assay and system suitability 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 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 QC project team member to provide QC 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 QC activities for cGMP operations.
Requires a Bachelor's Degree in Biochemistry, Chemistry, Microbiology, Molecular and Bellular Biology, or Biology (or closely related degree with these core courses as the foundation)
Six (6) years of quality control experience in the pharmaceutical industry providing guidance to Manufacturing Operations, QA, and other cGMP areas.
Project Management experience
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.
Mentoring experience required.
Direct experience is required in method qualification, method transfer, and method validation in accordance with ICH guidelines.
Direct experience is desired in participating and supporting regulatory inspections through explanations of methodologies, investigations, and/or laboratory systems.
Experience in method development is desired.
Knowledge of and the ability to implement CFR, USP, and ICH requirements is desired.
Knowledge of LIMS and Waters Empower Chromatography Data System is desired. Ability to implement and demonstrate testing in accordance with 21CFR11 is required.
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.
Visual Demands - Must be able to read and see clearly.
Temperaments/Mental Requirements - Frequently required to exercise judgment 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.
Desired Experience, Skills and Abilities\:
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.
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 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 person's 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.