Quality Engineer Document Control and Training

Job Description
When youre part of the team at Thermo Fisher Scientific, youll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and youll be supported in achieving your career goals.
This position will be responsible for managing the Internal Quality Audit System and Change Control System for Thermo Fisher Scientific Laboratory Chemicals Products in New Jersey. The successful candidate must have experience performing and reporting on Internal Audits and managing the Change Control system to ISO9001 standards, at least. The candidate will manage the Change Control system, driving product and process changes to completion by working with subject matter experts for individual tasks over 2 sites. The candidate will also be responsible for ensuring the annual internal audit plan is accomplished on time and supporting department heads and SMEs in developing responses to findings. Project management skills and managing multiple priorities while partnering with multiple departments are a must. Candidate must be a self-starter and able to work with little direct oversight. Regular reporting of analytics and metrics will be required.
Major Responsibilities:

  • Manage the Change Control system, which includes:

    • Sitting on all Change Control Team meetings

    • Input of all Change Requests into a tracking system

    • Following up on open changes with owners to ensure they are resolved and dispositions are made in a timely manner

    • Generate and monitor metrics for report out in Management Review and use these metrics to address improvement opportunities.

    • Improving the Change Control system as it moves into a more automated database

    • Own Change and Internal Audit procedures

    • Train to Change and Internal Audit processes and tools

  • Manage Internal Audit System, which includes:

    • Ensuring the Internal Audit Plan for two sites is adhered to as required by ISO9001 and 21CFR820

    • Coordinate with internal auditors to cover the requirements of the internal audit plan

    • Participate in internal audits as necessary

    • Document findings and communicate to affected department heads

    • Track findings and ensure the commitment dates are met

    • Track Internal Audit metrics for reporting at Management Review.

  • Familiarity with CAPA as required by ISO 9001 and 21CFR820

  • Participate in other QMS efforts such as CAPA, Non-conformances, document control, training, supplier quality, etc.

  • Participate in PPI (continuous improvement) events.

  • Perform other duties as assigned.

  • Responsibilities include Change Control ownership (75% time allocation) and Internal Audits ownership (25% time allocation)

Minimum Requirements/Qualifications:
BS in a technical field with at least 5 years of experience in a manufacturing environment. Certified, experienced internal auditor to ISO9001. 3 years of experience in Change Control. Significant experience may be considered in place of degree. Knowledge of the most recent version of ISO9001 and pending regulatory changes. Experience auditing to 21CFR preferred.
Non-Negotiable Hiring Criteria:

  • Proficient knowledge of Internal Auditing and Change Control practices in accordance with standards such as ISO9001 and 21 CFR 820

  • Process creation and implementation experience required for Change Control

  • Experience with QMS databases such as Master Control and TrackWise, including process improvement, user requirements, user acceptance testing.

  • Skilled at reporting metrics showing performance and trending; advanced data analysis skills a plus

  • Ability to manage numerous priorities and activities in parallel (project management)

  • Ability to review current processes and implement productivity and compliance improvements.

  • Strong people skills to be able to deal with various personalities and levels within and outside of the organization.

  • Excellent verbal and written communication skills; ability to write reports required.

  • Excellent organizational skills and be detail oriented.

  • Position will divide time between Bridgewater, NJ and Fair Lawn, NJ sites

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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