Quality Assurance Specialist IIYour Responsibilities
The Quality Assurance Specialist II 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. Your Tasks
- Review validation protocols, data and reports, as assigned
- Coordinate assigned quality systems, such as GMP training program, deviations, CAPAs, or change controls
- Perform annual product quality reviews and system reviews as assigned
- Review raw material records
- Provide support to customer and regulatory audits.
- Conduct internal audits as assigned
- Implement improvements in quality systems and SOPs
- Review and update assigned documents, such as SOPs, including line clearances, and shipment verification, equipment qualification and documentation control
- Provide technical assistance on all production & quality systems documents
- Organize and update document room files as required
- Assist with ad hoc QA projects and other duties as assigned
- A Bachelor's Degree in Chemistry or Biochemistry and a minimum of 3 years' experience in the GMP / Manufacturing setting
- 3 years' work experience in GMP manufacturing
- Experience in GMP manufacturing, 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
- Excellent 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
You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity.Interested
Please submit your application with full supporting documents and apply at:
Bachem Group is an Equal Opportunity Employer.
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at firstname.lastname@example.org or 844-463-6178.