20 days old

Product Release Specialist II

Merz North America Inc
Franksville, WI 53126
  • Job Code
    PRODU02229-00001

The Product Release Specialist II position will perform a variety of tasks to analyze pharmaceutical compounds, inspect incoming supplies and release Finished and OEM product. This position is expected to possess a familiarity with medical device manufacturing documentation review and release. The Product Release Specialist II is responsible for creating and maintaining files of required product conformance certifications. Oversee and/or assist with tasks related to the activities associated with operations of Merzs Quality System and as directed by the immediate supervisor and Quality Management.


Hours 230pm - 100am M-TH


Documentation Review


  • Ensure timely QA review of documentation to verify compliance to SOPs and regulatory requirements.

Final Release


  • Perform final review and release of finished Medical Device History Records.

Identifying Nonconformance


  • Identify and initiate NCA for nonconformance found during the final review of DHRs.

Change Control


  • Maintain expertise in quality systems (e.g. assist and review SOPs, initiate change control)

Training


  • Ensure training requirements are met and records are up to date.

Reporting


  • Maintain and update departmental metrics and required reports.

Assist


  • Assist with continuous improvement initiatives / projects within the Manufacturing and Quality departments.

Certifications


  • Create and maintain the Product Conformance Certificates specific to Merz North America, Inc.

Represent


  • Work closely with the Packaging Department to provide on-going Quality support. Represent QA at cross-functional meetings, providing input and decision making.

Further Tasks


  • Assist with Incoming Inspections, returns and training duties

Education


  • High School diploma Required

  • BS/BA in a Physical Science or related field

Professional experience


Minimum of 3-5 years experience in the medical device field or other Quality Control/Quality Assurance trade required


Knowledge, skills and abilities (incl. languages)


  • Proficient in Microsoft Office applications (e.g. Word, Excel, Access, etc.) required

  • Demonstrate effectiveness in ability to train others, drive results, and meet deadlines required

  • Familiarity with material, biocompatibility and microbiological test methods for evaluation of materials and finished medical devices. Required

  • Communicate effectively and follow detailed written and verbal instructions required

  • Cooperate with coworkers within an organized team environment. Required

Knowledge or methods


  • Knowledgeable in current GDP and GMP. Required

  • Working knowledge of FDA regulations and other applicable regulations required

  • Experience in Manufacturing operations

Personal skills


  • Detail oriented with a high quality of work. Required

  • Strong customer focus required

  • Ability to work with little or no supervision and make effective decisions required

Some cleanroom work may be required; no make-up or excessive amounts of jewelry allowed. The physical demands described below are representative of those that must be met by an employee to successfully perform the functions of this job.


Employee will be required to follow any other job-related instructions and to perform any other job-related duties required by their supervisor.

Experience

Required
  • 3 - 5 years: Minimum of 3-5 years experience in the medical device field or other Quality Control/Quality Assurance trade required

Education

Preferred
  • Bachelors or better

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 contractors legal duty to furnish information. 41 CFR 60-1.35(c)



See job description





Posted: 2021-04-21 Expires: 2021-05-20
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Product Release Specialist II

Merz North America Inc
Franksville, WI 53126

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