Quality Assurance Specialist II

A brief overview

The QA Specialist II performs the day-to-day activities of the QA department to ensure drug substances manufactured by Bachem comply with FDA and international regulatory requirements for research, pre-clinical, clinical, and commercial purposes. Individuals in this position review and process assigned GMP documents, provide cGMP guidance to other departments, and provide support to customer and regulatory audits. Additionally, to manage (i.e. reconcile, issue, and maintain) GMP documents and records and, to provide support in document management electronic systems (e.g. MasterControl)

What you will do

• 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)

Qualifications

• Bachelor's Degree in organic chemistry or related field required or
• Master's Degree in organic chemistry or related field preferred
• Bachelor's Degree in Science or related field and a minimum of 3 years’ experience in a GMP / Manufacturing setting required or
• Associate's Degree in Science or related field and a minimum of 5 years' experience in the GMP/Manufacturing setting required
• 3-5 years experience in Quality Assurance and/or Quality Control required and
• 3-5 years experience in internal auditing as well as working with regulatory agencies required and
• 3-5 years experience working in ISO 7 and ISO 8 control environment and support real time batch record review required
• 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
• Certified Quality Process Analyst - ASQ Preferred or
• CQA Preferred or
• CQE certification desired Preferred

Base Annual Salary Range: $77,308.00-$96,635.00