QC AssociateLocation Novato, California Apply
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. Come join our team and make a meaningful impact on patients’ lives.
The QC In-Process (QCIP) Associate is responsible for coordinating and implementing assay method validations, including execution of studies for microbiological and analytical test methods on in-process intermediates, bulk drug substance, and drug product. In addition, the QCIP Associate will provide technical expertise, knowledge and skills for the design and continuous improvement of QCIP test methods and provide support for routine make, assess, and release (MAR) operations. The candidate should be able to complete work under minimal supervision and within cGMP guidelines and have a working knowledge that includes but is not limited to the following assays: Endotoxin, Bioburden, Microbial identification and challenge studies, Aseptic technique, Protein determination by BCA, Bradford, and UV Absorbance, Enzyme activity, HPLC, and Total Organic Carbon.
The QCIP Associate must be able to interpret results against defined criteria and apply a degree of critical thinking as the subject matter expert. He/she must demonstrate an ability to evaluate results against trend reports and contribute to proactive troubleshooting of issues and/or atypical results.
In addition, the candidate should be detail-oriented, exhibit effective time management and communication skills, and be able to work in a team-oriented culture of open feedback. The candidate should also and have the ability to anticipate and implement solutions that actively prevent and/or remove obstacles related to ongoing issues and allow for continuous improvement.
Key issues in all work assignments must be identified regardless of complexity. The chosen candidate is expected to follow and be proficient in knowledge and theory behind SOPs, understand the rationale behind requirements, apply consistent critical thinking skills to routine and non-routine work, and facilitate decision-making forums that involve suitable SMEs. He/she should possess the ability to independently recognize, initiate, and investigate any deviations from procedures, and be versed in fully supporting reasoning for conclusions.
Information must be appropriately communicated and escalated to proper audiences. Attendance at team meetings with some facilitation of discussions is essential, providing focus and accounting for the impact of department initiatives to the greater organization. The chosen candidate will be proactive and invested in his/her role, and engage with colleagues to foster mutual respect and ensure the collective team environment carries an overall positive and productive atmosphere.
- Develop strategies and experimental design for validation protocol execution and supplemental studies, as appropriate. Coordinate and plan method validation activates, investigations, technical studies, harmonization activities, and method transfer protocols with internal/external customers.
- Author and review SOPs, OTJs, Validation protocols and reports. Implement system improvements and procedural revisions, with emphasis on increasing laboratory efficiencies and safety.
- Perform (as needed) microbiological and/or analytical method validation testing under applicable cGMP guidelines, as well as contribute to prompt reporting of results to meet required project timelines.
- Perform review of notebook studies, validation assays, and test records.
- Evaluate routine assay validity, calculate and summarize results, analyze data per expectations or specifications. Assist with compilation and verification of trend reports.
- Perform investigations and write-ups for Laboratory Investigation Reports, Deviations, Quality Events and provide ownership of associated CAPAs.
- Lead optimization and continuous improvement projects.
- Attend team huddles and department meetings, support discussions and formulate ideas for laboratory infrastructure improvements and method optimization.
- Provide input for assay scheduling and daily process prioritization.
- Apply proactive communication upon occurrence of compliance risks and deviations from laboratory procedures, perform record initiation within required timeframes.
- Support oversight of QC laboratory equipment functionality and management. Assist with coordination of CMMS processes such as equipment work orders and calibration due dates.
- Qualify as trainer for a variety of responsibilities, with alignment toward an established progression of subject matter expertise. Provide troubleshooting and technical training to less experienced staff.
- Collaborate with co-workers to appropriately share general housekeeping activity assignments, and ensure systems for laboratory maintenance are adequate for creating a consistent state of inspection readiness.
- Represent QC needs within special project teams or cross-functional groups.
- Perform other responsibilities as deemed necessary.
- Bachelor of Science degree.
- 5-8 years of relevant laboratory experience, with 4-5 years of QC specific experience.
- Detailed knowledge of quality management systems, current Good Manufacturing Practices, expertise with QC principles and compliance requirements.
- Demonstrated working knowledge and critical thinking with respect to certified functional activities, with subject matter expertise on a number of technical modules or QC management systems.
- Excellent documentation, written and verbal communication skills are essential.
- Must possess the ability to perform routine and non-routine tasks under minimal supervision while modeling advanced measures of initiative, self-direction, objectivity and team advocacy.
- Ability and willingness to provide input to the entire group, with proficiency as SME in both facilitating active and open discussion, and laying groundwork for logical decision making.
- Computer literacy is required, proficiency with Microsoft Word and Excel is essential, experience with Microsoft PowerPoint, Access, or Visio is desired.
- Working knowledge of statistics along with advanced software expertise, such as within JMP or LIMS, is optimal.
- Must have a quality service attitude and focus, exhibit flexibility and willingness to work additional hours to meet production or laboratory process requirements.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.