QA/QC Manager

COMPANY OVERVIEW Nittobo America Inc. was established in 1986. Our primary emphasis is the manufacturing and supply of antisera and calibrators in bulk quantities as raw material to immunodiagnostic assay manufacturers. We are ISO Certified (9001:2015).

COMPANY PHILOSOPHY The people in the Nittobo Group, with regard to all corporate activities and business development, contribute to the succession of our precious global environment for the next generations, with sustainable development and by providing eco-friendly products and services.

COMPANY MISSION STATEMENT To manufacture diagnostic products that create consistent value for our customers and contribute to a healthy and comfortable lifestyle; we will do this by managing our business with integrity, the highest ethical standards, and in a socially responsible manner.

POSITION DESCRIPTION: Establishes and directs the quality control systems to ensure raw and finished products meet specifications. Directly or through subordinates, manages the applications testing, and regulatory affairs compliance. Leads quality control, quality assurance, and applications technicians. All duties are performed in a manner that is consistent with the goals and policies of the company, as well as in compliance with ISO standards, where applicable.

Develops and manages customer complaints/feedbacks system, document control system, equipment maintenance and calibration system, internal and customer audits, finished goods, customer specifications, raw material/vendor specification and inspection system (CA/IA only), procedure and process standardization, and other activities leading to quality product and processes and consistent with GMP.

Performs quality control testing requiring the efficient and effective use of a variety of laboratory equipment and processes and ensures the QMS meets ISO 9001:2015 standard requirements and that the processes produce effective outputs.

Reviews and evaluates all activities associated with in process testing (CA/IA only) the new release of raw material, final products, and antigens.

Evaluates and reviews new testing methods based on new market trends.

Participate in company planning, problem solving and works closely with Divisional Director of QA/QC and executives.

Establishes procedures to ensure that all processes, procedures, data, and documents are kept confidential and the property of NTB-A, as well as maintaining knowledge of new testing methods based on new market ideas and trends and recommends or implements improvements.

Evaluates employee performance, salary increases and creates annual departmental budget.

SUPERVISORY RESPONSIBILITIES: This position directs and supervises the QA/QC Department. Carries out supervisory responsibilities by following the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance, recommending salary increases, addressing complaints, and resolving problems. This position supervises 7 – 12 employees.

QUALIFICATION REQUIREMENTS: Must be able to perform each essential duty satisfactorily. A valid Driver’s license is required in this position. The requirements listed below represent the knowledge, skill, and/or ability required. Reasonable accommodations will be made to enable individuals with disabilities to perform essential functions.

Candidates must be legally authorized to work in the U.S. on and on-going basis without sponsorship

EDUCATION and/or EXPERIENCE: Master’s Degree is preferred. Bachelor’s degree from a four-year college or university in biology or related life sciences; eight to ten years of experience and/or training or equivalent combination of education and experience, with three to five years of direct experience in the biotech or life science industries. Knowledge of ISO 9001:2015 global standard and federal regulations impacting the QA/QC department is also required.

LEADERSHIP: A demonstrated ability to lead people and get results through others. Provides leadership for problem resolution to facilitate rapid improvements and improved working relationships. Offers leadership in developing, improving, and implementing corporate policies and procedures in conjunction with management.

Job Type: Full-time

Pay: $90,000.00 - $115,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Retirement plan
• Tuition reimbursement
• Vision insurance

Education:

• Bachelor's (Required)

Experience:

• Manufacturing: 2 years (Preferred)

Work Location: In person

Salary : $90,000 - $115,000