Quality Assurance Document Specialist

Employer
PACT Pharma
Location
South San Francisco, California
Salary
Salary + Bonus + Pre IPO Equity
Posted
Sep 18, 2020
Ref
2020111
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

PACT Pharma is an exciting, well-funded clinical-stage company developing personalized adoptive T cell therapies for the eradication of solid tumors. Our private designer T cells are created by analyzing a patient’s individual tumor and engineering T cells to kill that specific tumor. 

If you desire a stimulating fast-paced environment, working with intelligent people who are making an impact in cancer, you will want to join the PACT Pharma team.  We are a rapidly expanding, innovative, and collaborative workforce working towards one main goal, eradicating cancer! 

We are in the San Francisco bay area, the heart of the world’s premier biotechnology research hub. PACT Pharma offers a competitive compensation and benefits package, including participation in the aggressive growth of the company in the form of stock option grants. 

We are currently recruiting for a Quality Assurance Document Specialist who will report to the Director, Quality Assurance Operations, and continue advancing PACT’s cutting edge engineered cell product. The ideal candidate is an experienced Documents Specialist with a track record of success in Clinical, GLP, and GMP environments. The job incumbent will be responsible for updating and filing documents, logs, and databases in support of compliance activities  This will be a unique opportunity to see your ideas rapidly translate into the clinic and impact patient lives. 

Responsibilities:

  • Coordinate and process documentation and training within Master Control, electronic Document Management System (MC-eQMS) to meet cGMP and ISO9001 requirements
  • Ensure policies, manuals, Standard Operation Procedures (SOP), Work Instructions (WI), Forms, and other controlled documents are in compliance with regulated QMS
  • Administer the scanning, filing, maintenance, and retrieving of all types of documents and quality records
  • Collaborate with Document Change Control (DCC) initiators to ensure accuracy of the change justifications and metadata
  • Print controlled cGMP logbook, log sheet, Master Batch Record (MBR), and labels to support upstream & downstream manufacturing process
  • Coordinate and maintain document training records utilizing Master Control-eQMS
  • Provide training on the document control & document training process
  • Prepare and present KPI status reports, as needed
  • Assign and monitors document numbers, part numbers, & update logs and databases
  • Coordinate the review and revision of procedures, specifications, and forms, as needed
  • Receive, review, control, and track documents per relevant process and procedures
  • Identify and implements improvements to the document control system
  • Perform other job duties as assigned 

Qualifications:

  • Bachelor’s degree with 5+ years of quality assurance or equivalent experience
  • Experience with Master Control Electronic Document Management System
  • Knowledge of documentation control requirements for the pharmaceutical industries
  • Working knowledge of cGMP and regulatory requirements
  • Solid knowledge of personal computer systems and desktop office applications, including Word, Excel, and PowerPoint
  • Experience with key cGMP Quality Systems (e.g. Change management, Deviation, CAPA, Documentation)
  • Strong verbal and written communication skills
  • Ability to build strong working relationships with multiple departments
  • Highly goal-driven approach and the ability to focus on time-sensitive objectives
  • Must be able to work independently with minimum supervision
  • Strong organizational skills, with the ability to successfully manage multiple priorities 

PACT Pharma is proud to be an equal opportunity employer and strives to build a diverse and inclusive team. We do not discriminate based on race, color, national origin, religion, gender, sexual orientation, age, marital status, veteran status, or disability status.