Quality Assurance Associate - Inhalation

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Job Description

The QA Associate is responsible for the Quality Systems as they relate to Change Controls, Training program, SOPs, Internal and External Audits and Investigating and responding to Customer complaints. This position ensures all Compliance activities are of the highest quality and meet all applicable SOPs and government standards. 

• Initiate, review, monitor and track all Change controls throughout the company. Lead a weekly Change Control meeting to ensure all change controls are properly closed in a timely manner
• Perform compliance audits of GMP related activities within the company. Ensure all activities are in accordance with the batch records, departmental SOP’s, GMP and DEA regulations.
• Perform the external audits for vendor qualification program and ensure the vendors are in good compliance status.
• Participate in any customer or regulatory audits at the company and provide the necessary support for the audit.
• Maintain all training records for each employee. Work closely with Department managers to identify training needs and conduct the necessary training. Identify training gaps and notify employees of the required training.
• Track the SOP’s review period and ensure all the SOPs are within the review period and notify the department heads regarding the revision and follow-up with the revision. Revise the general SOPs and train all personnel as necessary.
• Receive, Document, investigate and respond to customer complaints within the allotted timeframe.
• Perform any other activities assigned by the company

Qualification and Experience

• Bachelor’s/master’s degree in a Scientific Field
• Minimum 2 years experience in a pharmaceutical field.
• Ability to read, understand, speak and write English.
• Ability to communicate well with intra and inter departments professionally.

Competencies