Join our Talent Network
Skip to main content

QA Engineer, Document Control Specialist

This job posting is no longer active.

Location: Philadelphia, United States
Position Type: Unfixed Term
Job Function: Quality

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

Primary Purpose and Overall Objective of the Job:

The QA Engineer – Document Control Specialist is responsible for supporting the Quality Management System at the Philadelphia site by maintaining document controls and assisting with other quality projects at the site. Under the guidance of the Quality Manager the incumbent is responsible for,


Main Accountabilities:

  • Maintenance of quality system records including preparation, verification and filing of Quality documentation to ensure that it meets applicable customer, regulatory, and corporate requirements.
  • Assist employees in obtaining identification numbering for internal and external documents, and controlled documentation.
  • Responsible for initiating, verifying, and maintaining records for non-conformances, deviations, root-cause-investigations and CAPAs.
  • Responsible for maintaining Doc. Control KPIs
  • Assist with continuous improvement programs/projects to improved compliance to regulatory and industry standards.
  • Assist in employee training and maintain employee training records under the QMS.
  • Processing and review of document change requests.
  • Complete data entry in quality databases for new and modified documents.


Typical Studies-Experience, Skills, and Qualifications:


      • BA/BS Degree in a life science or related field and a minimum three (3) years of experience in related industry required. Advanced degree with one (1) plus years of experience preferred.

Skills and Qualifications:

  • Prior experience with Quality Management Systems procedures and document control preferred. Familiarity/knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (ISO9001, ISO13485, ISO17025) is a plus.
  • Experience managing nonconformances, investigation writing experience preferred.
  • Computer skills required, should be proficient with Microsoft Office Package (Excel, Word, etc.)
  • Competence in the use of Quality Tools and Techniques and knowledge of quality systems (SAP/LIMS/Trackwise) is a plus.
  • Excellent interpersonal skills and ability to work with all levels of an organization.
  • Ability to work independently and in a team environment.
  • Ability to prioritize and balance multiple deadlines in a fast-paced deadline driven environment.


Scope and Resources Accountability, Typical Performance Indicators:

  • Scope and Resources Accountability: N/A
  • Financial Indicators (revenue, budget, etc.): Site revenue, number and complexity of products, number of product launches per year.
  • Key Performance Indicators (KPIs): Conformity with quality standards and procedures, Document revision turnaround times, Customer complaints.
  • Key Contacts (internal/external) and Interfaces: Quality Director/Manager, R&D and Ops Department Heads, QC department, General Managers, Site / Subs Managers, other Functional Leaders.



Language A:

English  Fluent

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e.,,, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site or contact us at [email protected].

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

Share: share to e-mail