Quality Assurance Specialist II

A 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. This role involves reviewing and processing assigned GMP documents, providing cGMP guidance to other departments, supporting customer and regulatory audits, and managing GMP documents and records. Additionally, the role includes support for document management electronic systems (e.g., MasterControl).

Responsibilities

• Performs production room, dispensary, and shipment clearance verifications, as required.
• Revises established standard operating procedures (SOPs) and 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.
• Verifies scans of BPRs, chromatograms, etc., for accuracy and ensures documents are boxed and labeled correctly for archiving.
• Coordinates, reviews, and approves quality events.
• Provides training for new hires.
• Supports regulatory, customer, and internal audits.
• Drives continuous improvements and represents QA in process improvement project teams.
• Implements and maintains the Quality Management System.
• Scans, verifies, and archives GMP records (internal and external).
• Reviews and/or approves monitoring/trending data.
• Represents QA in project teams (e.g., harmonization of systems/processes across Bachem sites, implementation of new systems/processes).

Requirements

• 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.
• 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 environments and supporting 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.
• Ability to communicate effectively and function well in a team environment.
• Ability to troubleshoot and resolve problems.
• Certified Quality Process Analyst (ASQ), CQA, or CQE certification preferred.

Pay

Base annual salary range: $77,308.00–$106,298.50. Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.

Benefits

• Competitive pay.
• Annual performance bonus.
• Comprehensive medical, dental, and vision coverage.
• 401(k) plan with employer contribution.
• Paid vacation, personal, and sick days.