Sr. Specialist HPLC​/Lab Manager QC

Sr. Specialist Hplc / Lab Manager Qc

Partnering closely with the Senior Director of Quality Control, the Sr. Specialist HPLC / Lab Manager QC will help support the establishing efficient, compliant, and high-performing laboratory operations with a focus on HPLC and CE in a regulated GMP environment.

This role requires deep expertise in all aspects of HPLC testing and a sound understanding in CDS software, preferably Empower, Quality Control GMP operations and quality systems, along with demonstrated leadership capability and the ability to effectively influence teams and stakeholders across organizational and global environments.

Location:

Fremont, CA

Position Responsibilities:

• Serve as an HPLC subject matter expert and drive improvement of HPLC workflows and our Empower based CDS.
• Author and maintain analytical methods, validation and qualification documentation, and relevant laboratory procedures.
• Authoring analytical procedures and their associated validation and qualification documents for new analytical testing methods or equipment or training and mentoring junior QC team members therein
• Support troubleshooting and transfer tests from Analytical Development into GMP operations.
• Review and interpret analytical data to identify trends, assess risk, and initiate appropriate corrective actions.
• Lead investigations for deviations, including OOS, OOT, OOR, and OOE, performing root cause analysis and defining corrective and preventive actions.
• Act as a subject matter expert during client audits and regulatory inspections, representing QC analytical and operational processes.
• Implement Lean laboratory practices and drive continuous improvement to enhance efficiency and performance.
• Support cross-functional QC activities by providing cross-trained resources to address urgent analytical needs.
• Lead, coach, and develop a team of analysts to ensure high technical and performance standards.
• Establish and maintain compliant laboratory operations aligned with Bionova quality standards and regulatory requirements, including the definition and monitoring of key performance indicators.

Working Conditions:

This position requires work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 20 pounds independently.

Qualifications:

• Bachelor of Science degree or equivalent in a scientific field
• Minimum of 4 years of experience in analytical or quality control environments. Minimum of 2 years of GMP Quality Control Laboratory.
• Strong working knowledge of HPLC and CE analytics with expertise in method development and GMP validation.
• Experience in designing CDS workflows (data review, audit trails, design of workflows, custom fields…)
• Expertise in data analysis, trend analysis, and statistical methods.
• Excellent written and verbal communication skills to effectively document findings and present technical information.
• Working knowledge of GMP regulations and guidance (21 CFR, ICH, Eudralex etc.)
• Effective organization and planning skills. Demonstrated ability to deal with frequent changes, delays, or unexpected events
• Strong technical writing skills and expertise with GMP software (e.g. LIMS, Empower, or equivalent systems)
• Effective interpersonal and communication skills. Communication at all management levels and all staff is required.

The base compensation range for this role is $140,000-$170,000. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.

As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.