Quality Assurance Specialist II

 A Brief Overview

The Quality Assurance Specialist II/Sr Quality Assurnace 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 Specialist II/Sr Quality Assurance Specialist fulfills 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.

What you will do

• 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.)

Qualifications

• Bachelor's Degree in Science or related field and a

• Minimum of 3 years’ experience for Quality Assurance Specialist II 

• Minimum of 5 years' experience for Sr. Quality Assurance Specialist 

• Experience in GMP manufacturing environment, Quality Assurance and/or Quality Control

• Experience with GMP document control, validation, qualification and calibration.

• Experience in internal auditing as well as working with regulatory agencies.

• Experience with peptides (preferred)

• Ability to work in ISO7 and ISO8 control environment and support real time batch record review.

• 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

• Current knowledge of drug development activities in North America

Our people are passionate about what they do, the product they sell, and the customers they serve. If you're looking for an opportunity to be a part of a work family that values collaboration, innovation and dedication, we're the right company for you. 

Base Hourly Range:

• QA specialist II: 65,360 - 89,870

• Sr QA specialist : 72,640 - 99,880

Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.

Total Rewards 

We offer all Team Members 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. 

Corporate Social Responsibility 

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

Bachem Americas is an Equal Opportunity Employer 

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status