What are the responsibilities and job description for the Quality Assurance Senior Specialist position at Aditi Consulting?
Payrate : $33.00to $36.00 / hr
Summary :
Initiate and coordinate product complaints. Interface with call centers, various sites and business partners to ensure call intake process compliance. Complete and approve product complaints requiring no further investigation. Reconcile reported product complaints to ensure entry in CMIS. Perform return sample coordination and visual assessment. Archive documents related to product complaints. Requirements : Bachelor's Degree in Life Sciences or related field or the equivalent combination of education and / or experience. Typically 2 plus years of related quality assurance or manufacturing experience in a GMP pharmaceutical or medical device industry. Evaluate documentation and operation and documentation according to company guidelines. Be self motivated, attentive to details and able to prioritize and meet deadlines. Basic statistical mathematical skills including the ability to trend data. Basic project management skills. Independently understand, follow and implement instructions. Strong word processing, database and spreadsheet application skills. Strong organizational skills with the ability to manage multiple projects or assignments.
Day to Day Responsibilities :
- Provide quality advice and oversight to ensure products are manufactured, tested, stored, and distributed according to current good manufacturing procedures.
- Develop and maintain a working understanding of applicable requirements and best practices.
- Leverage knowledge and experience to provide risk-based Quality advice on strategies for successful investigation of deviations; as well as implementation of corrective actions, and change control
- Perform review and approval of GMP processes, procedures, documents, and records, including deviations, corrective actions, change controls, effectiveness verifications, standard operating procedures, batch records, and protocols.
- Review / approve validation documentation, protocols, reports supporting the following qualification / validation disciplines : Equipment, Computer, Process
- Review / approve equipment and computerized systems periodic review reports, as well as environmental qualification protocol reports
- Manage the change control process, ensuring changes are thoroughly evaluated for impact to quality, and strategies for implementation follow our processes and procedures.
- Collaborate with project teams to integrate quality considerations and controls into project planning and execution.
- Independently assess and prioritize quality risks across various functions and processes.
- Implement proactive measures to prevent potential issues and ensure a state of inspection readiness
- Drive continuous improvement initiatives at the site and network level to create value for the business.
Top 3 Must Have Skill Sets :
Compensation :
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate's qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries :
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.
AditiConsulting
Salary : $33 - $36
