Deerfield Management Companies

Quality Assurance Specialist

Job Locations US-MD-Gaithersburg
Job Post Information* : Posted Date 1 month ago(7/5/2022 12:41 PM)
ID
2022-1790
# of Openings
1
Category
Research & Development

Overview

The QA Specialist will participate in the day-to-day operations of QA. The QA Specialist will work collaboratively across internal functions including Manufacturing, Analytical/Process Development, Quality Control, Regulatory Affairs, and Supply Chain to ensure QA deliverables are met. Assist in the design of phase- appropriate QAD systems including implementation and continuous improvement to ensure patient safety and data integrity. Act as a point of contact (POC) on QA matters, internally and externally.

 

Responsibilities

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

  • Act as a Point of Contact (POC) and Subject Matter Expert (SME) on QA matters, internally and externally.
  • Assist in the design of phase-appropriate QA and QAD systems including implementation and continues improvement to ensure patient safety and data integrity.
  • Review and approve master and executed GMP documentation including production records, testing records, deviations, investigations, reports, protocols, change controls, SOPs and
  • Assist in the tracking and reporting of lot disposition status to management and other
  • Prepare lot release documents, including certificate of analyses (CoAs) for final management approval. Ensure resolution of all identified issues prior to lot disposition (e.g. investigations, deviations).
  • Act as first responder for on the floor quality issues in a timely manner, assists in the documentation of events and identifying required containment/corrective actions as
  • Write technical documents such as reports, change controls, and SOPs. Includes reviewing and approving these document types.
  • Ensure work is conducted following cGMP requirements and APT procedures and that QA deliverables are
  • Communicate and participate effectively and cross-functionally.
  • Participate in audits as needed (internal, regulatory, and/or partner).

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

  • Bachelor of Science degree / equivalent in life sciences or related
  • 5+ years of experience in the pharmaceutical and biotechnology
  • Strong knowledge of FDA and ex-US regulations in development through
  • Fluency with regularly used Microsoft software applications (Word, Excel, PowerPoint, SharePoint).
  • Experience with government contracting
  • Skilled in design and deployment of QA programs and
  • Ability to solve complex technical issues and drive to
  • Skill in building and maintaining cross functional relationships across
  • Ability to manage multiple priorities with a sense of urgency to meet
  • Adaptable to
  • Excellent communication skills; verbal and written; with various levels of internal and external
  • 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 hr@aphage.com and we will contact you if needed.

 

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