JOB SUMMARY: Work with manufacturing operations and QA/QC to support GMP and ISO compliance. Assist in developing processes and documentation for compliance purposes. Collaborate with multiple departments in the drafting and publishing of documentation and revise as necessary. Participate in training operations personnel to ensure GMP and ISO compliance. Participate in managing documents in the document control system (QT9). Assist in regulatory audits and provide internal audit support. This position is hybrid, working primarily remotely with 1-2 days onsite at our Grass Valley facility. Housing and relocation expenses can be discussed throughout the interview process.
ESSENTIAL DUTIES AND RESPONSIBILITIES: Other assignments, projects, and duties may be required:
- Assisting in QT9 document control system for GMP document.
- Co-managing corrective actions, training, SOPs, calibrations, internal and external audits, risk management, equipment files, customer support, supplier management, etc. in QT9
- Managing corrective action effectiveness evaluation in QT9
- Organizing and maintaining all GMP documents in QT9 (i. e. logbooks, forms, etc.)
- Composing and reviewing technical documentations such as technical reports, development reports, risk assessments, process validation protocol/reports.
- Supporting all activities related to document control in GMP Manufacturing.
- Controlled document preparation, routing, supporting document creation/change system.
- Publishing controlled copies of approved documents (SOPs, forms, procedures, production batch records, training material, training quiz, etc.)
- Trending all scientific and technical data on production batch records, environmental monitoring, stability studies, etc.
- Supporting management during regulatory agency, ISO, NSF, and customer audits.
- Other manufacturing document control related tasks as applicable.
- Associate degree as a minimum: bachelor degree in chemistry or biochemistry preferred.
- One year experience in a regulated industry as a minimum.
- One year experience in QT9 management as a minimum.
- GMP documentation experience preferred.
- Experience in scientific technical writing preferred, but not required.
- Experience in Podio Database program is a plus.
Wage: $40,000.00 – $50,000.00 salary (DOE)