Quality Systems Associate I at Merz North America Inc in Racine, Wisconsin

Job Description:

QMS Technical Support

• Responsible for resolution of EQMS tool issues or escalations to resolve technical and user concerns.

QMS System Improvements

• Responsible for supporting QMS improvements including system configuration, upgrades, and validation preparation, documentation and execution.

SOP Maintenance / Support

• Provide input in creation and/or review of internal operating procedures.  

Compliance to Regulatory Requirements

• Assist in ensuring applicability of current quality policies, procedures and objectives by keeping informed of the latest updates/modifications related to industry standards and federal regulations.

Quality Support

• Provide support for the Quality Assurance/Operations Departments and to other company departments as directed by Quality Systems Management.

Further Tasks

• Support Merz EQMS, as needed


• Support the creation and publishing of monthly and quarterly metrics for Quality Systems processes

Training

• Support EQMS tool training of individual users/groups as needed to ensure compliance

 

Education

• Bachelor’s Degree required


• Bachelor’s Degree in Computer Science and/or Life Sciences preferred

 

Professional experience

• 2 years of computer software support and/or related experience preferred

 

Knowledge, skills and abilities (incl. languages)

• Must be proficient in MS Word, Excel, and PowerPoint software programs.


• Must have excellent verbal and written communication skills and leadership skills


• Ability to work with company staff and communicate effectively throughout the organization is essential required


• Familiar with industry standards and Federal Regulations

Knowledge or methods

• Preferred experience with statistical analysis of data.


• GAMP


• Root Cause Analysis Tools

Personal skills

• Strong technical writing and general problem-solving skills

This job description is an overview intended to describe the general nature and level of work being performed by individuals assigned to this job. The descriptions above are not intended to be an exhaustive list of all responsibilities, duties and skills required of the job. All employees may have other duties assigned at any time. 

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)

Quality

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