Quality Manager of Lab Services

Description:

Who Are We?

Biolog is a leader in microbial identification, phenotypic cell profiling, and metabolic fingerprinting for microbial and mammalian cells. The main office is located in Hayward, CA. The company’s products enable the identification of thousands of species of bacteria, yeast, and fungi as well as characterization of human cells and mitochondria. Our second office is in Delaware; Biolog Lab Services, an innovator in microbial identification, currently offers contract laboratory services for microbial identification and enumeration to deliver critical, time-sensitive ID for pharmaceutical, probiotic, food and beverage, and personal care manufacturing operations using sequencing and MALDI-TOF mass spectrometry. Biolog products are available worldwide, either directly from the company or through its extensive network of international distributors.

What Do We Value?

We are passionate about all the ways our technology can impact R&D and industrial applications including microbial characterization and identification, synthetic biology, biomanufacturing, bioprocess development, metabolic and mitochondrial disorders, nutrition, toxicology, and drug discovery.

What is the Job all About?

The Quality Manager is responsible for implementing and maintaining the company’s Quality Management System in accordance with applicable regulatory and ISO standards, and customer expectations, and ensure that continuous improvement initiatives are being met.

Requirements:

Responsibilities:

It is expected the post holder will most influence the successful delivery of this result by:

1) Lead and oversee Quality Management System initiatives, policies, and procedures –

a. Implement and maintain robust quality control processes to ensure compliance with industry standards and regulations, driving continuous improvement initiatives across all aspects of operations.b. Coordinate the development and implementation of records for the Quality System, c. Write, review, and approve Quality Management System documentation.d. Oversee laboratory process validation, equipment qualifications and change control requirements.e. Manage regulatory registrations and permits and the associated reporting requirements, inspections, and company compliance.f. Support continuous improvement by critical evaluation of QMS and related systemsg. Manage and provide direction to Quality staff.

2) Monitor, inspect, & audit company processes and procedures for compliance to regulatory and accreditor standards –

a. Organize annual management review meetings and manage the outcomes.

b. Coordinate all company accreditation activities including annual internal ISO and technical audits.

c. Input, assign, and monitor all and preventative actions in the CAPA system.

d. Coordinate, review and approve the laboratory’s annual proficiency testing program.

e. Completes annual supplier evaluations for suppliers used in MIDI Labs.

3) Serve as Quality Management representative –

a. Review any new product or service offering for compliance to regulatory standards

b. Coordinate and facilitate customer and regulatory audits.

c. Act as liaison to customer and regulatory agencies for all Quality issues and documents.

d. Review and sign customer quality agreements, supplier surveys, quality questionnaires, etc.

e. Represents policies and ethics of the company as outlined in the company handbook in a professional manner, to customers and company employees in a leadership role.

f. Train personnel in regulatory requirements and Quality Management System activities.

g. Report performance of the Quality Management System, quality trending and any other quality issues to laboratory management monthly.

h. Assists with Quality related onboarding requirements of new hires.

i. Act as a customer liaison for the company at customer-facing events.

4) Other duties as assigned to meet business needs.

Requirements:

• Able to communicate effectively
• Excellent organizational skills
• Excellent Customer relationship and people skills; Customer focused
• Excellent problem-solving skills
• Ability to multitask and prioritize workload
• Self-starter with excellent time management skills, capable of working well within a team
• Generates creative solutions, thinking outside the box
• Leadership skills
• Bachelor's degree in science, engineering, or related field (or minimum of 5 years of Quality Assurance experience in a regulated industry – see below).
• Expertise in regulatory requirements including ISO 17025, 21 CFR part 211, USDA and/or cGMP/GLP.
• Understanding of technical laboratory services
• Computer skills – all Office software, LIMS and CAPA software
• Analytical or technical experience, using and/or validating scientific equipment or processes
• At least 5 years of experience in a Quality role for a regulated lab service, pharmaceutical, or technology company
• Experience implementing and maintaining a Quality Management System
• Experience training personnel on Quality issues
• Experience performing and being audited
• Leadership experience
• Ability to multitask with frequent interruptions is essential
• Schedule flexibility

Additional Information:

Generally, the work environment consists of ambient room temperature, lighting and traditional office equipment as found in a typical office or laboratory setting. While performing the duties of this job the employee is regularly required to sit and talk or hear. The employee is frequently required to walk; use hands to finger, handle or feel and reach with hands and arms. The employee is occasionally required to stand. The employee must occasionally lift and/or move up to 20 lbs. or less due to shipments received. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential job functions.

The role is on-site at our Newark, DE location.