Senior Associate Quality Control
About the Opportunity
We are seeking a skilled quality assurance specialist to join our team.
Duties and Responsibilities
* Develop and execute analytical methods with precision and accuracy.
* Conduct complex routine and non-routine procedures and assays.
* Evaluate, report, back-up/archive, trend and approve analytical data.
* Resolve issues and communicate effectively with stakeholders.
* Implement changes in controlled documents.
* Participate in audits, initiatives and projects within the department or organization.
* Review protocols and perform assay validation and equipment qualification/ verification as required.
* Introduce new laboratory techniques including method transfers, reports, validations and protocols.
* Contribute to regulatory filings.
* Investigate lab incidents as necessary.
* Monitor lab practices for compliance on a continuous basis.
* Approve lab results.
* Collaborate with external resources.
* Coordinate LIMS data for commercial and import testing on site where applicable.
* Represent the department/organization on various teams. May train others.
Requirements and Qualifications
* A Bachelor's degree in a Science related field is required.
* At least 3 years of experience in biopharmaceutical QC or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
* Strong background in Chemistry and Analytical testing is essential.
* Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
* Knowledge of Compendial testing would be advantageous.
What We Offer
Our company offers opportunities for growth and development.
Join our team and contribute to the success of our organization.