Established and growing Pharmaceutical CDMO seeks an experienced QA Associate for their state-of-the-art facility in Eastern, PA / New Jersey area.
This is an exciting opportunity to work on important, exciting and socially relevant projects with a successful leading edge company.
Note: This is a part time position requiring only 20 hours a week.
You will provide quality assurance (QA) support within the company and is responsible for issuance of documents to the scientists as required, filing and scanning of reports. Provide necessary support to the QA Manager during external audits. Provide scanned reports to the project management team when required by clients. In addition to this, the position may perform validation work in support of operations in laboratories and cleanroom areas including the equipment, personnel and area requirements.
This position is also responsible for helping keep the scheduling of activities related to audit commitments and help the Compliance Manager complete and report these activities on time.
This position would help keep the reconciliation of issued forms and follow-up on these to be completed and returned to QA on time.
Applicant should be able to contribute to the compliance of GxP operations by performing activities that would provide a high degree of assurance that compliance activities are handled properly and managed adequately.
Some activities are:
- Maintain notebook files including reconciliation of pages issued and physical files.
- Scanning and issuance of controlled documents to the project management group.
- Maintain personnel training files including training matrixes.
- Oversee the effective implementation of an efficient system of quality authored specific documents like protocols, and SOP’s.
- Maintain audit and audit findings response schedules.
To be considered for the exceptional career opportunity you must have at least the following:
- Minimum of AS, preferably a bachelor’s degree in Science
- Knowledge of cGMP/cGLP and Microsoft Office system, preferably.
- Preferably, minimum 2 years experience in pharmaceutical operations in QA/QC
This is a great opportunity to use your drug development skills with a company that recognizes and rewards top performers.