Quality Assurance Specialist II

Bachem AG•Vista, CA

1d•$77,308 - $96,635•Onsite

About The Position

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).

Requirements

Bachelor's Degree in Science or related field and a minimum of 3 years’ experience in a GMP / Manufacturing setting required
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
3-5 years experience in internal auditing as well as working with regulatory agencies required
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

Nice To Haves

Master's Degree in organic chemistry or related field preferred
Certified Quality Process Analyst - ASQ Preferred
CQA Preferred
CQE certification desired Preferred

Responsibilities

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)