Spec 2, Quality Document Sys Mgmt

MillenniumSoft Inc

Job Location:

Sparks, NV - USA

Monthly Salary: Not Disclosed

Posted on: 20 days ago

Vacancies: 1 Vacancy

Job Summary

Bill rate Job Description

Under general supervision responds to customer and internal requests with information and documents that meet the customers quality / regulatory needs.
Provides on-site audit support.
Maintains existing procedures at the Quality Systems level and below.
Investigates analyzes and develops solutions to a variety of problems of moderate scope and complexity while using regulations government guidance documents and standards as well as policies and procedures for guidance.
May prepare and maintain product documentation and records for ingredients and OEM products acquired from outside suppliers to support animal by-product and In-Vitro Diagnostics (IVDR) Regulation compliance.
May contribute to the maintenance of USDA and CDC Import/Transport Permits and USDA certificates related to product import/export.
May support maintenance of EDQM TSE Certificates of Suitability
May support maintenance of AOAC-RI Certification for identified products.
May be expected to make presentations at team meetings.
May support working with government agencies and international associates to assure the required permits certificates and related documents concerning animal by-product regulations are in place or provided and thereby assure the smooth import of acquired materials export of manufactured products around the world.

This position is based in our Sparks MD office with a Hybrid work schedule 8:00 AM 5:00 PM EST (Tuesday to Thursday on-site).
This position is a Termporary Position with only the possibility of Temporary to Permanent placement.
Requires a minimum of a bachelors degree in science engineering or other relevant discipline.
Min 3 years or a combination of equivalent education and experience.

Minimum Skills Required:

Bachelors degree (BS) in a scientific engineering or related technical discipline is required.
Basic knowledge of quality systems regulations ISO Quality System and Medical Device standards.
Ability to effectively communicate both verbally and in writing to all levels within the organization and external to the organization.
Ability to work in teams including large multifunctional teams and independently obtain results as required with minimal supervision. Proven ability to use initiative and drive to achieve results.
Excellent attention to detail with a high degree of accuracy and the ability to work independently and in team situations.
Ability to identify analyze develop and present solutions for problems of moderate scope and complexity.
Ability to collect analyze data and present results to others orally or in writing.
Must be able to comprehend and summarize data and document into reports.
Must be Self-motivated organized and detail oriented.
Ability to handle multiple task assignments and effectively manage time and priorities to meet deadlines.
Ability to develop work plans and manage them to meet agreed upon goals.
Skilled in Microsoft software; excellent Excel data extraction and analysis skills; SAP proficiency strongly preferred; ability to learn and master other software programs.

Desired Skills:

Project Management Experience desirable.
Knowledge of Global Animal By-Product Regulations desirable.
Knowledge of USP/EP/JP desirable
Professional certification is an advantage (e.g. RAC Six Sigma etc.).

Bill rate Job Description Under general supervision responds to customer and internal requests with information and documents that meet the customers quality / regulatory needs. Provides on-site audit support. Maintains existing procedures at the Quality Systems level and below. Investigates analyz...

Bill rate Job Description

Under general supervision responds to customer and internal requests with information and documents that meet the customers quality / regulatory needs.
Provides on-site audit support.
Maintains existing procedures at the Quality Systems level and below.
Investigates analyzes and develops solutions to a variety of problems of moderate scope and complexity while using regulations government guidance documents and standards as well as policies and procedures for guidance.
May prepare and maintain product documentation and records for ingredients and OEM products acquired from outside suppliers to support animal by-product and In-Vitro Diagnostics (IVDR) Regulation compliance.
May contribute to the maintenance of USDA and CDC Import/Transport Permits and USDA certificates related to product import/export.
May support maintenance of EDQM TSE Certificates of Suitability
May support maintenance of AOAC-RI Certification for identified products.
May be expected to make presentations at team meetings.
May support working with government agencies and international associates to assure the required permits certificates and related documents concerning animal by-product regulations are in place or provided and thereby assure the smooth import of acquired materials export of manufactured products around the world.

Minimum Skills Required:

Bachelors degree (BS) in a scientific engineering or related technical discipline is required.
Basic knowledge of quality systems regulations ISO Quality System and Medical Device standards.
Ability to effectively communicate both verbally and in writing to all levels within the organization and external to the organization.
Ability to work in teams including large multifunctional teams and independently obtain results as required with minimal supervision. Proven ability to use initiative and drive to achieve results.
Excellent attention to detail with a high degree of accuracy and the ability to work independently and in team situations.
Ability to identify analyze develop and present solutions for problems of moderate scope and complexity.
Ability to collect analyze data and present results to others orally or in writing.
Must be able to comprehend and summarize data and document into reports.
Must be Self-motivated organized and detail oriented.
Ability to handle multiple task assignments and effectively manage time and priorities to meet deadlines.
Ability to develop work plans and manage them to meet agreed upon goals.
Skilled in Microsoft software; excellent Excel data extraction and analysis skills; SAP proficiency strongly preferred; ability to learn and master other software programs.