Job description

At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you’re a recent college graduate or seeking your next career opportunity, it’s time to discover your future at Altasciences. We are better together and together We Are Altasciences.

The QA Associate will support the continued development and implementation of a practical quality management system. Must possess a quality-oriented mind and technical knowledge to complement interpersonal skills of flexibility and collaboration. Effectively communicate and maintain open and timely execution of QA tasks across multi-disciplinary teams.

Main responsibilities:

• Review and providing feedback on GMP documentation including equipment qualifications, analytical method qualifications, stability protocols, product monographs, and SOPs.
• Review and release raw materials and components to be used in the manufacture of clinical and/or commercial products.
• Provide QA support and oversight during the production and testing of drug product.
• Review executed batch records, analytical test results and raw data as part of product release. As required, work to resolve identified issues to support timely release of product that conforms to specifications.
• Support and review investigations related to deviations or out-of-specifications and the implementation of corrective and preventive actions that mitigate potential for reoccurrence.
• Communicate quality-related input to project teams while participating in project or client meetings.
• Provide new employee orientation and curricula issuance in coordination with department heads. Ensure ongoing employee compliance with training procedures.
• Participate in the planning and execution of customer audits. As required, support the drafting of responses to client audit findings to assure they meet the client’s expectations.
• Participate in regulatory inspections to ensure successful results.
• Participate in supplier quality assessments to ensure suppliers and subcontractors to be used are properly qualified in accordance with the supplier management program.

Desired profile:

• Minimum of a Bachelor’s degree in a scientific field, or equivalent experience
• Minimum three (3) years related experience in QA or five (5) years in QC
• Strong analytical skills and attention to details required

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Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences!

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