QA Documentation (QAD) Specialist
Gaithersburg, MD 
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Posted 12 days ago
Job Description
QA Documentation (QAD) Specialist
Job Locations US-MD-Gaithersburg
Job Post Information* : Posted Date 2 months ago(7/12/2022 5:47 PM)
ID
2022-1795
# of Openings
1
Category
Research & Development
Overview

Adaptive Phage Therapeutics (APT) is a clinical-stage biotech advancing therapies to treat multi-drug resistant infections. We are on a mission to address today's - and tomorrow's - toughest infections. We are looking for intelligent and motivated people to help us reach those goals.

The Quality Assurance Documentation (QAD) Specialist will support daily management and maintenance of paper and electronic documentation in compliance with regulations. The QAD Specialist will work collaboratively across internal functions including Manufacturing, Analytical/Process Development, Quality Assurance, Regulatory Affairs, and Supply Chain to ensure QAD deliverables are met. They will assist in the design of phase-appropriate QAD systems including implementation and continuous improvement to ensure compliant and efficient management of controlled documents per current Good Manufacturing Practice (cGMP) regulations. They will act as internal point of contact (POC) on QAD matters.

Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

  • Responsible for day-to-day operations of QAD.
  • Manage and facilitate the system(s) for creation and revision of master GMP documents, including Standard Operating Procedures (SOP), company-wide.
  • Manage and facilitate the system(s) for issuance and reconciliation of controlled documents.
  • Responsible for QAD archival, retrieval, and provision of controlled documents, including hardcopy and electronic files.
  • Author and/or review standard operating procedures for QAD processes, as assigned.
  • Ensure QAD work is conducted following cGMP requirements and APT procedures and that QAD deliverables are met.
  • Other duties as needed.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required for this job. Duties, responsibilities, & activities may change at any time with or without notice.

Qualifications
  • 5+ years of experience in the pharmaceutical or biotechnology industries
  • Knowledge of FDA Good Manufacturing Practice (GMP) regulations.
  • Fluency with regularly used Microsoft software applications (MS Word, MS Excel, MS PowerPoint, SharePoint)
  • Experience with electronic document management systems a plus.
  • Expert level computer literacy, particularly MS Word, Adobe, and SharePoint.
  • Understanding of cGMP document management systems.
  • Skill in building and maintaining cross functional relationships across company areas.
  • Ability to manage multiple priorities to meet timelines.
  • Excellent communication skills; verbal and written; with various levels of internal and external organizations.
  • Full COVID-19 vaccination required; APT employees are required to be fully vaccinated against COVID-19 to work on the premises.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job and will be available to the candidate upon request.

APT is an Equal Opportunity/Affirmative Action employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. APT seeks to diversify its work force and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Notice to Third-Party Recruiters/Staffing Agencies: Recruitment is managed through the Adaptive Phage Therapeutics Human Resources department. Resumes will only be accepted from staffing agency/recruiters if there is a signed contract in place. Recruiters are requested to not contact our hiring managers or employees directly to inquire about open positions or to present candidates. In the event a staffing agency/third-party recruiter submits a resume without a contract in place, the candidate submitted will be considered unsolicited and treated as if the candidate submitted their resume directly to Adaptive Phage Therapeutics, and no fee/payment will be paid. Recruiters interested in working with Adaptive Phage Therapeutics can submit their information to and we will contact you if needed.

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Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
5+ years
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