Associate II, QC Technical

Who We Are

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

SUMMARY 

The Associate II, QC Technical is responsible for owning and facilitating Quality Control laboratory investigation processes within the quality management system (Veeva QMS), with activities prioritized according to business needs and timelines. The primary focus of this position is to collaborate with QC supervisors, leads, and analysts to plan, coordinate, and advance investigations; identify probable contributing factors and/or root cause(s) for laboratory incidents; and facilitate the timely completion, review, approval, and closure of investigation records to support critical business objectives. The role manages a variety of record types, including laboratory investigations, deviations, calibration events, and environmental monitoring alert, action, and adverse trend evaluations.

 RESPONSIBILITIES

• Facilitate and complete laboratory investigations (LIRs) for OOS, OOT, OOE, and system suitability/test acceptance failures, prioritizing activities according to product impact, compliance risk, operational urgency, and critical business need. 

• Facilitate and complete deviation investigations related to QC laboratories and procedures, excursions, and adverse trends, prioritizing activities according to product impact, compliance risk, operational urgency, and critical business need.

• Serve as QC’s primary contact for documenting investigation findings and preparing trend or technical reports as necessary.

• Gather data, observe processes, and perform personnel interviews based on business priorities.

• Lead cross-functional root cause analysis using appropriate tools.

• Assign and prioritize child records based on risk, business need, and timelines.

• Align reviewers and SMEs on the investigation path and evolving priorities.

• Define appropriate CAPAs and effectiveness checks, providing ownership as needed.

• Identify trends and partner with appropriate teams for resolution.

• Define expected process impacts and monitor effectiveness with SMEs.

• Maintain QC investigations in compliance with company and regulatory standards.

• Partner with management and QA to prioritize and close QMS records within timelines aligned to business urgency as needed.

• Identify improvement opportunities and promptly escalate risks, barriers, or compliance concerns to appropriate management. 

• Attend huddles as needed to provide investigation status updates and communicate support needs. 

• Perform other assigned duties based on business needs and management direction.

 EXPERIENCE

Required Skills:

• 6+ years’ experience working in a cGxP laboratory or related setting.

• Working knowledge of Root Cause Analysis (RCA) and Operational Excellence mechanisms.

• Knowledge with core chemistry principles and both microbiological and analytical methodologies such as purification, pH, bioburden, endotoxin, spectrophotometry, chromatography, ELISA, PCR, PAGE/CE, Activity and Enzyme Kinetics.

• High degree of accuracy and attention to detail.

• Strong written, particularly technical writing, and verbal communication skills.

• Strong time management, critical thinking, problem solving, decision making and leadership skills.

• Proficiency with QMS record and control document management software such as Veeva.

• Competence with usage of Microsoft Office Professional Suite (Word, Excel, PowerPoint, Outlook/Teams)

 Desired Skills:

• Demonstrated fluency of cGMP / GLP principles and industry standards throughout 8+ years of direct QC/QA operation involvement.

• Ability to dynamically manage multiple and complex priorities to meet changing business needs.

• Detailed experience with performing RCA as well as determining how appropriate remediations can be to interface with requirements of current processes and regulatory requirements.

• Experience with FDA, EP and/or JP regulations with some extent of previous responsibilities pertaining to audit preparedness.

• Exposure or participation of real-time process and test method performance monitoring.

• Deployment of baseline statistical principles and applications such as control limits, variance, regression analysis, outlier detection, variable frameworks for performance comparability.

• Knowledge of utilizing Microsoft Power Platform to increase operational efficiencies.

• Demonstrated passion for continuous improvement and readily working within a team-oriented and collaborative environment.

EDUCATION

B.S./B.A. degree in relative science disciplines (major in biology – biochemistry – chemistry preferred). 

EQUIPMENT 

Vast majority of responsibilities will be served outside of a laboratory setting. A certain extent of interaction with QC lab operations will be required however is not expected to involve interfacing with specific pieces of instrumentation or equipment. Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.

CONTACTS 

Job incumbent will interact with members of QC Leadership Team (QCLT), including direct manager of QC Technical, and Quality Contacts in QA to effectively prioritize and complete timely writeup and approval of robust investigations. Also to occur routinely is collaboration with team members, to seek guidance and alignment as well as mentor less experienced investigators. In addition, building cross-functional relationships with Manufacturing, QA Compliance, or QC ops at other company sites to convey and represent ongoing lessons learned and continuous improvement to systems or procedures will be expected on an as-needed basis. 

SUPERVISOR RESPONSIBILITY 

This position is not configured to have direct reports and no supervisor responsibilities apply. 

SHIFT DETAILS 

This position will principally operate during normal business hours from Monday – Friday, with some degree of flexibility required to collaborate with necessary teams to deliver effective and timely investigations.

ONSITE, REMOTE, OR FLEXIBLE 

This is a flexible role requiring 2-3 days on-site on a weekly basis at the BPI Novato site. The on-site schedule may increase based on business priorities, operational needs, and team requirements.

TRAVEL REQUIRED 

Travel is not anticipated to be required to facilitate routine responsibilities. 

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.


Ireland Safety Responsibility Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.
Ireland Safety Responsibility
Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.