The Ritedose Corporation
The Quality Assurance Associate II is responsible for maintaining all training of a QAA I in addition to the review of controlled documents in accordance with applicable SOPs. The QA Associate II will document review activities and status in the applicable Quality Systems. The purpose of QA review is to ensure the document, product, or process under assessment is compliant with all TRC, client, and regulatory agency requirements.
Responsibilities
Batch record review for completeness, accuracy, and compliance to TRC standards and coordinate required corrections
Verification of critical processing steps (sterilization cycles, mix times, machine settings, etc.)
Escalate deviations and other issues impacting quality to Management and the affected department
Issue product Certificate of Analysis or Conformance
Track/trend the batch record review process- identify and initiate improvements to process
Perform Product Complaint batch record review
Maintain a professional team-oriented working relationship with fellow employees
Follow written and verbal procedures as directed by Supervisor
Copy / Scan batch records and QMS documentation
Follow TRC SOPs, safety and health guidelines and cGMP guidelines
Levels
New Hire (level 1): Complete initial training and review level 1 batch records.
Experienced (level 2): Complete all training and review level 1 and 2 batch records. Able to perform batch release.
Senior (level 3): Perform all above requirements. Able to review executed Validation & Development batches as well as create/revise QA SOPs and Work Instructions.
Qualifications
Minimum of Associates degree with 1 year of relevant experience, Bachelor degree, or 3 years relevant experience
Proficient with current word processing, spreadsheets, and database software
A high level of integrity and attention to detail
Ability to work independently as well as to participate in and contribute to a team-oriented work environment by developing positive working relationships within Quality and between other departments
Ability to handle and establish multiple priorities and meet expectations with minimal supervision
Strong oral and written communication skills
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Responsibilities
Batch record review for completeness, accuracy, and compliance to TRC standards and coordinate required corrections
Verification of critical processing steps (sterilization cycles, mix times, machine settings, etc.)
Escalate deviations and other issues impacting quality to Management and the affected department
Issue product Certificate of Analysis or Conformance
Track/trend the batch record review process- identify and initiate improvements to process
Perform Product Complaint batch record review
Maintain a professional team-oriented working relationship with fellow employees
Follow written and verbal procedures as directed by Supervisor
Copy / Scan batch records and QMS documentation
Follow TRC SOPs, safety and health guidelines and cGMP guidelines
Levels
New Hire (level 1): Complete initial training and review level 1 batch records.
Experienced (level 2): Complete all training and review level 1 and 2 batch records. Able to perform batch release.
Senior (level 3): Perform all above requirements. Able to review executed Validation & Development batches as well as create/revise QA SOPs and Work Instructions.
Qualifications
Minimum of Associates degree with 1 year of relevant experience, Bachelor degree, or 3 years relevant experience
Proficient with current word processing, spreadsheets, and database software
A high level of integrity and attention to detail
Ability to work independently as well as to participate in and contribute to a team-oriented work environment by developing positive working relationships within Quality and between other departments
Ability to handle and establish multiple priorities and meet expectations with minimal supervision
Strong oral and written communication skills
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