Scientist - Lead Investigator (Technical Operations)

Job description

Title: Scientist - Lead Investigator (Technical Operations)

Location: Novato, CA

Position Summary:
The position is responsible for conducting, performing and coordinating product investigations initiated by CSI (Customer Service Incidents)/Complaints, CAPA, process gap analysis which includes facilitating investigation, generating investigation reports, ensuring completeness and consistency with complaint documentation/investigation documentation, compliant to regulatory standards (ISO 13485 and ISO 9001). A successful candidate will work collaboratively with the Technical Support Team, Manufacturing Department, Technical Development Department, Quality Department, Master Planning Department, Commercial/Customer Service Team and EH&S teams.

Areas of Responsibility:
To perform this job successfully, an individual must be able to perform each essential function satisfactorily.
• Understand customer use and manufacturing processes for product produced.
• Perform investigations independently or as part of a team, as required.
• Track, investigate and closure of product complaints (CSI (Customer Service Incidents)/Complaints) to ensure adherence to established timelines and procedures.
• Track, coordinate, conduct and closure of investigations emerging from CAPAs, process gap analysis, etc. by collaborating with key stakeholders/cross functional partners to ensure adherence to established timelines and procedures.
• Work in collaboration with cross functional partners to investigate complaints and subsequently document the evaluation actions taken and conclusions reached in accordance to established procedures.
• Conduct failure analysis, problem solving and root cause analysis (RCA) to identify the root cause of the problem. Suggest corrective and preventive actions relative to all investigations.
• Escalate expedited complaints/investigations to management.
• Coordinate and manage the investigations pipeline. Generate, track and trend investigations by producing KPIs - Closure turnaround time, number of investigations open v. close, number of issues escalated to Technology Development, RCA Trends.
• Compile, submit and present monthly reports to key stakeholders including executive summary on the quantity and types of investigations along with KPIs.
• Assure regulatory compliance of the complaint program is maintained. Perform periodic reviews of program-related SOPs / processes and revise as necessary. When required, perform gap analysis to ensure the process meets regulatory compliance and close identified gaps through SOP revision or other actions.
• Support conduct of internal and external cGMP audits and regulatory agency inspections, and completion of post-audit / inspection commitments.
• Support Technology Development, Manufacturing, and Quality management initiatives and objectives.
• In addition, this role can be called on to support other quality related activities, including but not limited to data mining, statistical analysis, report generation, data pulls, coordination of other activities as indicated by the manager/department head.

Other Skills, Abilities, and Competencies:
• Able to work cross functionally with all departments and exhibiting core values of Passion, Integrity, Curiosity, Brilliance and Respect.
• Results oriented, while demonstrating accountability, flexibility, trust and collaboration.
• Demonstrates strong organization skills, analytical and root cause thinking.
• Ability to work in a fast paced environment and to work within set timelines.
• Professional presence and strong attention to detail.
• Proven technical skills in GMP oligonucleotide manufacturing or similar.
• Technical proficiency that enables effective collaboration with cross functional partners.
• Strong verbal, written, presentation and communication skills.
• Independent problem-solving abilities.
• Demonstrated command of Manufacturing MES systems and analytical software systems.
• Knowledge of the regulatory compliance - ISO 13485 and ISO 9001.
• Working knowledge of complaint handling, CAPA/SCAR systems, and basic statistical data analysis.
• Served as a SME for a production process.
• Ability to project manage and demonstration of leadership without authority.

Qualifications:
Education/Experience/Licenses/Certifications:

• Requires a bachelor's degree or related technical experience.
• A minimum of 3 years' experience in a technical/quality related role, and/or demonstration of ability to meet the requirements of a CSI (Customer Service Incidents)/Complaints Investigator.
• Understanding of design controls, risk management, statistical technique, complaints, Non-conformance/Deviations, GMP, and regulatory compliance.

Technology/Equipment Skills:
Microsoft Office, Outlook, Word, Excel, Teams and Project software. Use of a web browser.

You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

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