Über die Tätigkeit
The Quality Specialist assists and assures compliance with all FDA, cGMP and regulatory requirements for B&B Pharmaceuticals. The position oversees the development and implementation of internal regulations, guidelines and procedures with the aim of meeting or exceeding the regulatory requirements. The goal of the Quality Specialist is to assist in managing the systems required in guaranteeing the quality within all B&B processes, continuously attaining optimal quality.
- Guarantee the quality within the entire flow of product, from receipt of raw material to release of product, with the aim of continuously attaining optimal quality.
- Assist in all aspects of quality systems, including Change Control, Investigations, CAPA, Validation systems to ensure compliance, and timely and accurate completion of all reporting events.
- Ensure compliance of site policies and procedures by every employee for all processes.
- Identify compliance issues and conduct thorough internal investigations of compliance issues with the aim of continuously looking for process improvements and ruling out non-compliance issues.
- Conduct periodic internal reviews or audits with the aim of ensuring that compliance procedures are followed.
- Assist management with the renewal and addition of any regulatory licenses, as needed.
- Manage and maintain all revisions to label templates as well as creating any new labels for incoming products.
- Create and maintain all B&B customer-facing Certificate of Analysis’.
- Create and maintain all B&B customer-facing SDS’
- Manage sampling of incoming product for testing as well as creating bulk CofA’s.
- Manage all testing results received as well as the relationship with the testing facilities.
- Manage and schedule all needed annual calibrations of equipment, including but not limited to balances and printers, temperature mapping while working with the production schedules.
- Assist management with the maintaining and implementation of Master Control.
- Manage MOC progress and maintain a meeting schedule.
Qualified candidates will possess the following:
- B.S. or B.A in Sciences or a relevant field with a minimum of 1 year in Quality Control or Assurance.
- 2-4 years previous experience within a cGMP setting: including pharmaceuticals, medical devices, or food industry is strongly preferred.
- Microsoft Suite (Word, Excel, SharePoint) experience strongly preferred.
- Ability to work independently with little to no management oversight.
This opportunity includes a competitive salary, comprehensive benefits including generous paid time off, 401k contributions, and performance benefits.