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Quality Assurance Associate

Job Description:

The Quality Assurance Associate will work in the Quality Assurance department to support the manufacturing process (incoming raw materials inspection, manufacturing, and final product release testing activities), documentation of all records, and maintenance of procedures.  To support all activities to assure that all products are defect free and cGMP compliant with technical specifications.  The following is a list of activities, at minimum, to be performed for this position:

  • Edit, type and manage documents per the controlled documentation system following standard operating procedures and cGMP guidelines.  To file and maintain all documents, reports, and records stored in the QA Document Control Room. Maintain the QA Master Document Index database.
  • Read various instructions accompanying draft to determine format and content required.
  • Review document for punctuation/grammar, formatting, and content for conformity to company’s document system requirements.  To review for completeness and accuracy, ensuring references to other quality systems (process change control, deviations, CAPA) are included when needed.
  • Communicate with various departments on procedure and specification updates and the required personnel training to ensure timely issuance of the documents. Copy and distribute newly revised documents and table of contents to the various departments.
  • Assist manufacturing as a quality representative and reviewer during the manufacturing process.
  • Conduct quality required line clearances during the manufacturing process.
  • Conduct and collect raw material samples during the incoming inspection process.
  • Assist in the inventory controls of materials in the warehouse and inside the production areas.
  • Coordinate and prioritize document change workload according to due dates or priority.
  • Assist QA Manager in maintaining the integrity of the company’s quality system.
  • Participate in deviation investigations and support documentation of all corrective actions.

 

Requirement:

  • 2-3 years GMP experience in pharmaceutical manufacturing facility
  • Excellent problem solving and interpersonal communication skills.
  • Computer proficiency and working with MS Office applications (Word, Excel, etc.)
  • Experience with an electronic document system in a manufacturing or other production environment
  • Experience in a high workload environment with tight deadlines
  • Technical writing experience
  • Knowledge of scientific terminology
  • Ability to organize, prioritize, and manage your workload to meet deadlines is an ongoing requirement.
  • Quick thinking and problem solving abilities are essential.
  • Flexibility and adaptability to change is essential.

 

Physical Demands

  • Must be able to occasionally lift and carry items weighing up to approximately 25 lbs.
  • Must be able to walk around facility, regularly required to sit, stand, walk, reach with arms

 

Required Education:

  • BS preferably in Chemistry, Biology or related field.
  • Excellent proofreading and English usage ability is required.
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