POSITION PURPOSE:
This position is responsible to assist and coordinate quality procedures and policies to cGMP compliance under 3 party certifying body’s guidelines and FDA cGMP requirements. Examples of such required support include: conducting investigation to identify required CAPAs (Corrective and Preventive Actions), guide CAPA implementation process, provide training support for new programs, change controls, trainings resulting from NCRs, and CAPAs. This position will be supporting both company sites located in Ayer and Brockton, MA.

EDUCATION, CERTIFICATIONS AND EXPERIENCE:

• Bachelor’s degree preferred; Engineering, Science, Business Management or equivalent experience.
• 2+ years-experience in a food manufacturing environment, biotechnology, medical device, or nutraceuticals preferred.
• Prior experience in ISO regulated environment is preferred.
• ISO 9001 trained and certified is highly desirable.
• Certified Quality Engineer (CQE) certification is desirable.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Excellent oral, written and computer communication skills.
• Ability to communicate and transfer data analytics knowledge to team members.
• Strong math and science-related technical skills.
• Proficient in Microsoft applications (word, excel, access, and PowerPoint) and SharePoint.
• Ability to train and coach individuals on ISO requirements.
• Ability to present data to an audience in an effective manner in a public forum.

WORKING CONDITIONS:

• Majority of work is completed in an office setting working inside a controlled temperature environment. Occasional work on the manufacturing floor or outside is required.
• May perform activities in an environment containing hazardous elements and requiring safety awareness and adherence to all safety and GMP policies and guidelines.
• Work must be performed in a safe manner for personal protection and for the protection of other team members.

PHYSICAL REQUIREMENTS:

• Position requires the ability to sit up to 6 hours per day.
• Ability to stand, walk, bend over, and reach above head on a regular basis
• Ability to lift or carry up to 25 pounds occasionally and repetitive use of hands/arms for writing, filing, and computer work.
• Ability to wear required PPEs as required when in the manufacturing environment.

PRIMARY RESPONSIBILITIES:

Functional

• Act as the subject matter expert on ISO systems through performing the following:
  • Leverage internal and external resources to document an ISO compliant QMS.
  • Roll out ISO programs and train individuals that have a role in ensuring required compliance.
• Ensure the quality system is established, implemented, and maintained through internal auditing.
• Responsible for establishing, administering, and maintaining an ISO compliant internal auditing program.
• Responsible for maintaining the ISO QMS to comply with quality certifications and working with certifying bodies to schedule and re-schedule audits.
• Facilitate effective, thorough, prompt execution of investigation, CAPAs and troubleshooting by coordinating the required resources to drive resolution.
• Analyze and report on quality systems data as basis for improvement.
• Lead maintenance of documentation and records supporting ISO QMS compliance.
• Assist in ensuring quality and food safety goals are met by analyzing performance data and providing it to quality and operations management.
• Responsible for knowing and communicating quality and food safety regulations, as defined through the QMS and AJICO.
• Provide input into required resources to achieve and maintain compliance.
• Investigate NCRs, OOSs, customer complaints, deviation, and other quality related events to determine the root cause.

Inter-department Cooperation, Process Development and Personnel Development

• Assist in problem resolution and setting deadlines to ensure timely completion of work.
• Assist in developing goals and objective for department team, provide quarterly feedback.
• Coach and train other team members to improve work related skills.
• Help build and maintain a positive work environment.

Promote and Comply with Safety, Environmental and Quality Objectives

• Maintain business ethics, integrity, and reputation through compliance with state, federal, certifying bodies, and AJICO guidelines and regulations.
• Maintain ISO 9001 status in all areas of work within the department.
• Assist in achieving FSSC 2200 certification status when it has been determined to pursue it.
• Support CAPA directives and support ACI facilities needs as it pertains to RCA activities.
• Other duties as required.

The statements contained herein reflect general details as necessary to describe the principal functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned.

Education

• Bachelors or better in Biochemistry or related field
• Bachelors or better in Business Administration or related field
• Bachelors or better in Biomedical Engineering or related field
• Bachelors or better in Engineering or related field

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)