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QA/QC Associate

Human BioSciences Inc Gaithersburg, MD
  • Posted: over a month ago
  • $50,000 to $65,000 Annually
  • Full-Time

Responsibilities:

  • In-process Quality Assurance which includes manufacturing, filling, on-floor visual inspection, and packaging.
  • Handling Quality Management systems (Deviations, Change controls, Market complaints, Quality Risk Management & CAPA programs)
  • Process Validation and Cleaning Validation
  • Annual Product Review and Continues process verifications.
  • Document creation, issuance, and control
  • Create, review, and revise SOPs
  • Batch records review and release program
  • Assist with the document control for all GMP related activities
  • Plan, estimate, specify and evolve the QA planning
  • Verifying that raw materials or components involved in the production process are of suitable quality
  • Assessing whether employees need training to prevent nonconformances during production/packaging
  • Oversee all new hire GMP training requirements as well as monitoring and maintaining all GMP training records
  • Some in process Quality Control testing
  • Other duties as assigned by manager

Skills required:

  • 0-3 years knowledge and working experience with all aspects of quality assurance, which relate to a pharmaceutical / medical device development organization.
  • Bachelor’s degree in science, chemistry, or related field
  • Ability to work independently and in a group on a variety of projects
  • Ability to maintain a high degree of accuracy and attention to detail
  • Ability to handle a fast-paced, multi-tasking environment, and prioritize effectively
  • Planning, organization, and execution skills
  • Strong problem-solving techniques and ability to make sound decisions
  • A thorough knowledge and understanding of Canadian, US FDA and European regulations (GMP)
  • Excellent verbal and written communication skills required

To be considered, please click "Apply Now."

Human BioSciences Inc

Human BioSciences, Inc. (“HBS”) is a multinational biotechnology company which has been designing, manufacturing, distributing, and marketing a range of advanced collagen-based wound care products for almost thirty years. HBS’s proprietary FDA cleared and Medicare reimbursable Kollagen technology improves patient’s lives by making wound management fast, effective, and affordable. Join our team to help disrupt the wound care industry and make healing accessible to everyone.

Address

940 Clopper Rd, Gaithersburg, MD 20878
Gaithersburg, MD
USA

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