Job Role Overview
We are seeking a highly skilled Senior Associate Quality Control professional to join our organization. This is an excellent opportunity for individuals who want to work with a company that is renowned for its excellence in the pharmaceutical industry.
Key Responsibilities:
* Plan and perform complex analytical methods and procedures with high efficiency and accuracy.
* Report, evaluate, backup/archive, trend and approve analytical data.
* Troubleshoot, solve problems and communicate with stakeholders.
* Initiate and 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/verifications when required.
* Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
* May contribute to regulatory filings.
* May conduct lab investigations as necessary.
* Evaluate lab practices for compliance on a continuous basis.
* Approve lab results.
* May interact with outside resources.
* LIMS data coordination of commercial and import testing on site where applicable.
* May represent the department/organization on various teams. May train others.
Requirements:
* Bachelor's degree in a Science related field is required.
* 3+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
* Strong background in Chemistry and Analytical testing is required.
* Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
* Experience with analytical techniques such as Compendial testing would also be advantageous.