QA Specialist II

Job#: 2022528

Job Description:

• Works in conjunction with the Quality team and management to maintain a quality management system that complies with the requirements of the current standard.
• Review batch records and other relevant documents
• Release and rejection of materials, intermediates, packaging, and labeling materials, as applicable
• Review In process forms, protocols, and records for adherence to Good Documentation Practices (GDP).
• Collect and organize the Certificate of Analysis (CoA)s and Safety Data Sheet (SDS) from vendors.
• Communicate with vendors as needed to obtain the necessary documentation for incoming materials. 
• Generate the CoA, BSE/TSE statements, and other documents for BBP final products as needed.
• Maintain the Quality Records and production documentation within eQMS.
• Maintain the Training Record for all functional areas.
• Provide the quality document to the customer upon request.
• Qualify and approve the prospective vendor.
• Maintain vendor files with applicable documents.
• Assist in Quality planning and conducting periodic checks of production and laboratory areas.
• Assist Quality Assurance Specialist III in hosting internal and external audits.
• Assist Quality Assurance Specialist III in the management of client questionnaires, surveys, and qualification forms.
• Assist Quality Assurance Specialist III in the management of eQMS.
• Assist in records control of QMS and production documentation.
• Assist Quality Assurance Specialist III in drafting and updates of QMS documentation as needed.
• Assist Quality Assurance Specialist III in maintaining the Quality Records and production documentation within eQMS.
• Assist in additional duties delegated from Quality Assurance Specialist III and Quality Lead.
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• Minimum 1-3 years of relevant experience.
• Ability to follow instructions precisely, recognize deviations, and recommend corrective action within the scope of training.
• Preferably strong knowledge of ISO 13485 and GMP
• Have strong written and verbal communication skills, a detail-oriented work ethic, and the ability to understand recognized regulations such as ISO and GMP.
• Ability to troubleshoot within the scope of training.
• Ability to work independently with adherence to quality, production, and customer expectations and timelines.
• Preferably strong knowledge of chemistry
• Computer literate and experienced with Microsoft Office. Demonstrated skills in developing and organizing systems for the management of information.
• Demonstrated ability to meet deadlines, multitask, and change priorities while maintaining productivity.
• Ability to work well independently and in a team environmen\\

EEO 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 [email protected] or 844-463-6178.