QA Operations Specialist

Responsibilities:

• Excellent employment opportunity for a as QA Operations Specialist in the Frederick, MD area. 100% onsite
• We are seeking a highly motivated individual to join us as QA Operations Specialist at our commercial manufacturing site.
• Provide Quality Assurance oversight of Commercial Manufacturing, Materials Management, and Quality Control areas.
• Incumbent must meet the Company Covid Policy prior to starting.
• This position will work 4/10-hour days, Sunday to Wednesday, 7:00AM - 5:30PM
• Work with the Commercial Manufacturing, Quality Control, Materials Management and Facilities/Engineering departments as a Quality Assurance representative.
• Coordinate and facilitate Quality Assurance related production and production related activities, including on-the-floor Quality support to manufacturing, QC and Warehouse.
• Provides Clerical and Administrative support related to documentation processes and systems.
• Scans, verifies, and archives documentation and records as needed
• Ensure that tests are performed, and products are manufactured in compliance with the company specifications, regulatory and GMP guidelines.
• Support development of SOPs and review/approve SOPs to ensure quality objectives are met
• Compile and verify all batch related documents into a final product lot disposition package
• Review and approve executed Manufacturing Production Records for regulatory and company compliance
• Provides support to clients on the process of documents in the DMS and word processing tasks as needed.
• Participates in function meetings.
• Notifies manager of compliance questions and issues.
• Provides additional support and assistance on tasks and projects as directed by management.
• Willing to work on a weekend shift as needed.
• These duties can be delegated to designated deputies of a satisfactory qualification level as needed.
  

Experience:

• Bachelor's Degree in Technical discipline (Biology/Chemistry/Microbiology/Engineering or related field) with a minimum of 1-3 years of experience in Quality Assurance or a GMP related field within a Biotechnology, Biologics, or Pharmaceutical Manufacturing facility.
• Knowledge of GMP, SOPs and quality systems.
• Ability to effectively negotiate and build collaboration amongst individuals.
• Strong interpersonal, verbal and written communication skills.
• Experience with change control practices and strategies.
• General knowledge of aseptic manufacturing processes.
• Proficient in MS Word, Excel, PowerPoint and other applications.
• Ability to communicate and work independently with Scientific/Technical personnel.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities.