Process Improvement Associate

The Asahi Kasei Group operates with a commitment of creating for tomorrow.  Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Bionique Testing Laboratories LLC (Bionique) has been a leading global provider of mycoplasma testing services for the biopharmaceutical industry for over 30 years. Bionique offers the full breadth of services from lot and Final Drug Product release testing per regulatory guidelines to a GMP compliant Real-Time PCR assay to support clients’ needs from concept to clinical trials and commercialization for biopharmaceutical and cell therapy products. Bionique’s experience and expertise extends to development and validation of rapid microbiological methods to support abbreviated release timelines. Additional services such as regulatory and compliance consultancy add to Bionique’s unique position in this niche analytical testing space. Located in Saranac Lake, NY, Bionique is an FDA registered and GMP compliant contract testing facility. Bionique aims to offer unsurpassed quality mycoplasma testing services to meet the specific scientific and regulatory needs of each client and partner.

Company:

Bionique Testing Laboratories LLC

Job Description:

Summary:

The Process Improvement Associate will assist in the development of Standard Operating Procedures (SOPs) for new services, oversee the conversion of new and existing services into digital workflows (LIMS SOPs), and ensure efficient training and knowledge transfer to laboratory staff. This position will serve as the subject matter expert (SME) for events, investigations, and Corrective and Preventive Actions (CAPA), collaborating with the Quality Department to identify and propose solutions to Laboratory Management aimed at effectively addressing and resolving laboratory-related issues.

Key Accountabilities and Responsibilities:

• SOP Development and Digital Conversion
  • Assist in the creation of SOPs for new services
  • Leads the seamless conversion of new and existing laboratory workflows into a digital framework, including integration into LIMS.
  • Collaborates with the Process Improvement Manager and laboratory testing team to ensure workflows are properly mapped, optimized, and implemented in the digital system.
  • SOP Tracking: monitor the editing status of new and current Testing Group SOPs and Data Change Forms (DCFs) requiring updates, providing editing assistance as needed from Analysts.
  • Quality SOP Review: Evaluate existing SOPs to ensure all relevant references align with the new SOPs for LIMS.
  • Decision Tree Review: Test and review Decision Trees and Tables created by the Mycoplasma Testing Group for all Diagnostic Tests to validate their functionality and accuracy.
  • Identify and Resolve Exceptions: Identify and suggest resolutions for unforeseen exceptions withing the LIMS, ensuring smooth and efficient operation.
• Training and Knowledge Management
  • Design and create, in collaboration with Lab Management, comprehensive training programs for laboratory staff on new and existing assays, focusing on both technical and procedural knowledge.
  • Collaborate in the development and execution of training schedules, materials, and assessments and assist in the design and creation of a Training Matrix for all job types within LIMS to facilitate consistent training and onboarding.
  • Ensure ongoing training needs are identified and met to maintain a high level of competency and compliance.
• SME for Events, Investigations and CAPA
  • Serve as the point person for event investigations within the testing laboratory, working closely with the Quality department to assess root causes, perform impact assessments, and recommend and implement corrective and preventive actions in alignment with Laboratory Manager
  • Provide expert guidance on the creation and revision of SOPs as part of the CAPA process.
  • Collaborate with cross-functional teams to ensure the timely and effective resolution of any lab-related issues that may impact quality, compliance, or operational efficiency.
• Additional duties as assigned

Additional Accountabilities and Responsibilities

• Works independently and proactively with minimal direction and completes tasks as assigned
• Proactively keeps manager informed of progress and communicates effectively with colleagues as necessary to achieve assigned tasks and goals
• Highly organized and delivers on commitments without reminders
• Driven to continuously improve individual work and laboratory processes
• Strong critical thinking and problem-solving skills required
• Ability to adhere to a standard timeline and escalate actions appropriately for resolution in a timely manner

Requirements:

• Bachelor’s degree or higher in cell biology, microbiology, biochemistry, or related scientific field. Equivalent combination of education, training and experience may be substituted.
• A minimum of 3 years’ laboratory experience working in CGMP microbiology or cell culture lab
• Team oriented individual with excellent communication skills
• Advanced knowledge and experience in aseptic techniques and laboratory IT systems
• Outstanding communication skills and the ability to work independently with minimal direction
• Must be detail-oriented
• Enthusiasm for learning and contributing to process improvement

Physical Requirements:

• Ability to work for prolonged periods sitting on a chair and working at a computer/desk.

Pay Rate:

• The base compensation range for this role is $60,000-$70,000. Base Compensation is influenced by many factors including, but not limited to: position level, time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business/economic conditions. 

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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.

Salary : $60,000 - $70,000