Über die Tätigkeit
Candidate will work with Quality Assurance Lead as a Compliance Quality Assistant to ensure compliance of manufacturing processes in a GMP environment. This person will serve as an extension to the lead of compliance in regards to compliance oversight, which includes internal tracking systems and other areas that support manufacturing and regulatory agencies. Candidate will be working closely with other supporting members within the Quality Assurance Team supporting with track and trend of Change Controls, Deviations and CAPA closure. Candidate will need to understand sterile process, Good Documentation Practices (GDP), and current Good Manufacturing Practices (cGMP).
- Enter information in system to support compliance such as CAPAs, DEVs, CCR. Compile information for site lead using tracking systems in place.
- Follow GMP guidelines and adhere to SOPs and GMP requirements.
- Communicate QA with multiple departments and different levels of managements on status of compliance.
- Able to multi-task and manage projects within quality system. Support internal and external audits.
- Knowledge of pharmaceutical and or 503B environment and requirements.
- Experience working in a regulated environment (GMP)
- Ability to handle multi-task activities to support regulatory visits.
- Computer skills in excel, word, power point.
- Desire to work in an office setting as this position is not laboratory focused Detail oriented, ability to get along with a variety of different personalities, multitasking skills, and works well under pressure
- Strong verbal and written communication skills Technical writing and review ability
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.