Quality Assurance Specialist II

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.

Responsibilities include reviewing and processing assigned GMP documents, providing cGMP guidance to other departments, and supporting customer and regulatory audits. The role manages GMP documents and records, and provides support in document management electronic systems such as Master Control.

• 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)

• 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 Power Point
• 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

$77,308.00-$96,635.00

We offer a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.

Bachem takes responsibility for future generations by careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop new approaches for enhancing employees’ environmental awareness. Eco Vadis has awarded Bachem Gold Medal status in their assessment of Bachem.

As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.

Please note:

unsolicited resumes from recruitment agencies will not be considered.