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Quality Assurance Associate ( QA Pharmaceutical)

Company: Granules Pharmaceuticals
Location: Chantilly
Posted on: February 15, 2019

Job Description:

Description:
The QA Associate ensures compliance with cGMP and internal policies, procedures and specifications. This position is responsible for performing inspections, batch record review, and quality system functions in accordance with cGMP and related company SOPs, state, federal and local laws as applicable. This person should be knowledgeable of cGMP requirements, FDA regulations and ICH guidelines. This person is also responsible for driving the site change control, site incident/deviation/complaint investigation and CAPA programs. The persons is responsible for the execution and oversight of the cleaning and process validation activities as well.Responsibilities:

  • Ensure products meet approved company policies, process and procedures.
  • Responsible for scheduling change control committee meetings interfacing primarily with technical, quality and manufacturing groups.
  • Perform and support maintenance and closure activities of documents such as reports, change controls and protocol review.
  • Drive the timely implemenation and closure of change controls while ensuring compliance to applicable quality standards and change control procedures.
  • Author and review standard operating procedures.
  • Prepare and execute cleaning validation/verification documents along eith calculation of the acceptance critieria for all equipment available at the site.
  • Prepare and execute process validation/verification documents and author reports for the executed process vaildation/verification activities.
  • Develops, assigns code numbers and maintains logs of all reported incidents of non-compliance, investigations, planned and unplanned deviations, CAPA.
  • Initiating follow-up with departments involved in investigations
  • Tracks and manages the system for CAPAs, compliants, non-conformances, and investigations. To include classificaiton of complaints, completion of investigations, and failure analyses with thorough and effective documentation.
  • Present investigations during audits and inspections.
  • Perfrm and suppor maintenance and closure activities of documents such as reports, exceptions/deviations, CAPAs, change controls and compliants.
  • Other duties as assigned
  • PM18.

    Requirements:
    Knowledge & Skills:--- Demonstrate knowledge in process and cleaning validation/qualification.--- Knowledge of Quality Management Systems, including FDA compliance standards, cGMP regulations/guidelines.--- Knowledge of USFDA regulations/guidances and ICH guidances.--- Knowledge of Change Control/Deviation management and CAPA identification/implementation.--- Proficient in Microsoft Word, Excel, Power Point.--- Ability to analyze data/information and to assess and resolve complex issues, as required.--- Ability to work and communicate with cross-functional teams.--- Ability to manage multiple priorities and re-prioritize tasks, as required.--- Flexible and able to adapt to company growth and evolving responsibilities.--- Strong attention to detail and excellent organization.--- Excellent oral and written communication skills.Experience & Education:--- Bachelor Degree in a Natural Sciences (i.e. Biology, Chemistry), Pharmacy, or Engineering.--- At least Two to five (5) years experience in a quality assurance role in a cGMP-regulated environment.Physical Requirements:--- While performing the duties of this job, the employee is regularly required to, stand, sit, talk, hear, and use hands and fingers to operate a computer and telephone keyboard.--- Light to moderate lifting up to 10-15 lbs is required.Travel:Up to 5% travel maybe necessary PI107709139

    Keywords: Granules Pharmaceuticals, Chantilly , Quality Assurance Associate ( QA Pharmaceutical), Healthcare , Chantilly, Virginia

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