About this role
Role Overview
- Performs production room, dispensary and shipment clearance verifications, as required
- Revises established standard operating procedures (SOPs) as well as other GMP documents (e.g. stability protocols, raw material specifications, EM trend reports) as assigned
- Manages GMP documentation and their workflows as required by the department
- Verify scans of BPRs, chromatograms, etc. for accuracy and ensure documents are boxed, labeled correctly for archiving
- Coordinate, review and approval of quality events
- Training of new hires
- Provides support to regulatory, customer, and internal audits
- Drives continuous improvements and represents QA in process improvement project teams
- Implements and maintains Quality Management System
- Scan, verify and archive GMP records (internal and external)
- Review and/or approval of monitoring / trending data
- Represent QA in project teams (e.g. – harmonization of systems / processes across Bachem sites, implementation of new systems / processes)
Requirements
- Bachelor's degree in a science related field and a minimum of 3 years’ experience in a GMP manufacturing setting or Associates in a science related field and a minimum of 5 years' experience in the GMP manufacturing setting
- 3-5 years’ experience in Quality Assurance and/or Quality Control
- 3-5 years’ experience in internal auditing as well as working with regulatory agencies
- 3-5 years’ experience working in ISO 7 and ISO 8 control environment and support real time batch record review
- Ability to review scans of BPRs and chromatograms with high accuracy
- Knowledge of cGMP and FDA regulations and guidance(s)
- Knowledge of Quality Management Systems
- Knowledge of GxP
- Proficient computer knowledge, including Microsoft Word, Excel, and PowerPoint
- Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
- Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
- Ability to work independently and manage one’s time
- Communicate effectively and ability to function well in a team environment
- Ability to troubleshoot and resolve problems
Benefits
- competitive pay
- annual performance bonus
- generous benefit package with comprehensive Medical/Dental/Vision coverage
- 401(k) plan with employer contribution
- paid vacation
- personal and sick days