Quality Assurance Document Control (QA/DC) Assistant I

Posted 2 months ago

Quality Assurance Document Control (QA/DC) Assistant I

Department :  Quality Assurance

QA/DC position for filing and archiving of Good Manufacturing Practices (GMP) documents, updating/creating training records, document formatting/revision, and other document processing.  The QADC Assistant works under the direct supervision of the Manager of QADC.

Education and Experience: 

  • High School Diploma or equivalent
  • 1–3 years’ experience in Quality Assurance document processing in a pharmaceutical, biotechnology, or biopharmaceutical environment preferred

Skills/Abilities:

  • Proficient in Microsoft Word, Excel, Outlook, and Access; Adobe Acrobat
  • Microsoft Visio and/or Project knowledge a plus
  • Knowledge and experience in Good Documentation Practices
  • Strong organizational skills and attention to detail
  • Accurate typing and data entry
  • Excellent verbal and written communication
  • Ability to work independently and in a team environment
  • Experience with MasterControl (or other pharmaceutical QMS) a plus
  • Able to gown into clean room garments and work within GMP clean room environments
  • Able to lift/carry 20 lbs.

Responsibilities:

  • Reviewing records for deficiencies
  • Reviewing GMP documentation for format
  • Reviewing and organizing training
  • Assigning and documenting record numbers and locations of records, both manually and electronically
  • Fulfilling and archiving document change requests, copy requests, logbooks, and batch records
  • Archiving records according to established system
  • Ensure filing system is well organized
  • Produce and maintain Microsoft Access databases and Excel workbooks
  • Produce/update QADC documentation
  • Protect organization’s value by keeping intellectual property and documentation confidential
  • Contribute to team effort by accomplishing related tasks
  • Travel between two CEL-SCI GMP facilities (North Baltimore and Elkridge MD to perform the above functions will be required)
  • Other duties as assigned

Work Hours:

Position is full time, on site.  Monday through Friday – 8am-4:30pm with 30-minute lunch or 8am-5pm with 1hr lunch (hours may vary on occasion).  Occasional early and late work and weekend work may be required.

Location:

Elkridge, MD and North Baltimore, MD.  May require travel between CEL-SCI’s Baltimore and Elkridge Maryland locations.

We offer competitive salaries, outstanding comprehensive benefits, and Employee Stock Options. 

Please submit cv/resume and cover letter to careers@cel-sci.com.  Reference the job title in the subject line of the email 

DISCLAIMER:

CEL-SCI Corporation is committed to a policy of equal employment opportunity. CEL-SCI will recruit, hire, train, and promote into all job titles the most qualified individuals, without regard to race, color, creed, protected veteran status or disability, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

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