The swing shift Supervisor, GxP Document Control & Training function is responsible for ensuring that Good Documentation Practices (GDP) are maintained for Intarcia. This role is responsible for directly managing the hands-on day-to-day processing of all GxP Documents and Records in a manual and/or electronic environment, directly managing all secure on and offsite storage and retrieval of archival documents, and maintaining the secure Quality Records Library. The incumbent is also responsible for the management and maintenance of the GxP employee training records, both manual and electonic per regulatory requirements. This role works directly with IT, QA, Validation, Regulatory, Manufacturing, Facilities, Supply Chain, and other personnel at various levels of authority who author and execute GxP documentation, or who require or deliver GxP training, to help ensure compliant manufacturing, clinical development and regulatory activities. The Supervisor will further support QADC management in all audits, inspections, and due diligence efforts, as necessary.
Primary Duties and Responsibilities:
Maintain, process, and shepherd all documents, production, training, equipment, and facility records for all GxP operations through their respective lifecycles on a daily basis as assigned and according to work instructions and SOPs.
Create/issue/maintain controlled forms, logs, lot numbers, work instructions, log books, document numbers, labels, etc. (including but not limited to SOPs, protocols, methods, reports, batch records, specifications, drawings, validation plans, and maintenance logs).
Support the GxP training program, including onboarding, issuing curricula, maintaining the training database, providing reports on training compliance as necessary, securing training documentation, managing on-the-job training requirements and qualified trainers
Retrieve and respond to requests for information or training securely and in a timely manner; negotiate revisions/timeline changes with originators in a professional manner, maintaining a customer service disposition at all times.
Maintain QADC supplies and QADC equipment (reporting issues to IT, Facilities, etc).
Support all QMS activities (CAPA, DRs, OOS, etc) in hardcopy and electronically, including document control, training management, processes, and troubleshooting/user support.
Assist with the maintenance of secure on- and offsite record storage processes and procedures, including efficient and accurate retrievability and inventory controls
Other duties as assigned to support the Quality Assurance function, the facility, and the company.
A minimum Bachelor’s degree in a scientific discipline is required.
5+ years in the drug/device pharmaceutical industry in QA GMP functions preferably for combination aseptic products in clinical studies (Phase I to III) commercial. Good knowledge of US and EU regulations.
At least 6 years of hands-on Document Control and Training combined experience (a combination of manual and electronic systems is preferred) Strong working knowledge of cGMP regulations (for e.g., 21CFR4, 21CFR211, 21CFR820, ISO13485), and ICH guidance’s.
Demonstrated Quality Assurance or Quality Control experience in the pharmaceutical / biotech industry.
Ability to multitask, juggle priorities, and perform independently in a fast-paced work environment.
Strong communication skills allowing for close, clear, and continuous communication (in person and via email) with interfacing departments.
Strong attention to detail and expert editorial skills.
Strong proficiency in MS Office suite (especially Word and Excel) and Adobe Acrobat Pro (skills test will be administered).
Prior experience with electronic document management systems (EDMS), learning management systems (LMS), and/or electronic quality management systems (EQMS), preferred.
Collaborative spirit and ability to be flexible, and to work in an entrepreneurial, multi-hat environment, a must.