Quality Assurance Specialist
The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide.
Bachem. Leading Partner in Tides
In order to continue our organic growth, we are constantly looking for talent.
The Quality Assurance Specialist will assist in the day-to-day activities of the Site QA – Manufacturing and Batch Compliance department, conducting BPR issuance, timely batch record review, Production room and daily Dispensary clearances and GMP shipment clearances for the manufacture of drug substances in compliance with FDA and international regulatory requirements for research, pre-clinical, clinical and commercial products.
The Quality Assurance Specialistfulfills a critical role for Quality Assurance. This individual will conduct real time batch record review, perform internal audits, contribute to GMP system improvements, write technical documents, and review GMP documentation and reports. This individual must also provide GMP and related training.
- Review executed BPRs to support final product releases
- Print and issue BPRs to Production department
- Perform timely and accurate Production room and daily Dispensary clearances
- Perform timely and accurate GMP shipment clearances
- Review and edit technical protocols / reports (including executed working protocols)
- Support customer and regulatory audits; participate in responses to observations
- Review customer feedback, comments, corrections; participate in responses
- Write, review and edit revised SOPs / Forms through MasterControl
- Verify scans of BPRs, chromatograms, etc. for accuracy and ensure documents are boxed, labeled correctly for archiving
- Initiate and approve change requirements (CRs) to ensure future MBPR revisions
- Provide cGMP compliance guidance to other departments and continuous improvement of BTO’s quality system
- Represent QA in project teams (e.g. – harmonization of systems / processes across Bachem sites, implementation of new systems / processes)
- Assess and/or approve shipment temperature excursion alarms in LiberoManager software
- Review and/or approval of monitoring / trending data
- Assist QA – Document Control group as necessary
- Train new QA hires in job-specific responsibilities
- Others as assigned by supervisor (e.g. – QA safety representative, quarterly internal audits, etc.)
- Bachelor’s Degree in Science or related field and a minimum of 3 years’ experience in a GMP / Manufacturing setting
- Experience in GMP manufacturing environment, Quality Assurance and/or Quality Control
- Experience with GMP document control, validation, qualification and calibration
- Ability to work in ISO7 and ISO8 control environment and support real time batch record review
- Experience in internal auditing as well as working with regulatory agencies
- Effective written and oral communication skills
- Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
- Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
- Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues.
- Detail oriented with the ability to troubleshoot and resolve problems
- Ability to work independently and manage one’s time
- Communicate effectively and ability to function well in a team environment
- Experience with peptides
- Current knowledge of drug development activities in North America