What are the responsibilities and job description for the Senior QA Associate - 2nd Shift (3p-11p) position at Lyndra Therapeutics?
About Us
Lyndra Therapeutics is a clinical-stage biopharmaceutical company pioneering long-acting oral therapies. Lyndra is focused on commercializing therapies in central nervous system (CNS) disorders, which would most benefit from dramatically reduced dosing frequency. Lyndra’s lead product candidate, oral weekly risperidone (LYN-005), is being developed for the treatment of people living with schizophrenia and bipolar 1 disorder. The company is also committed to advancing its platform to tackle major public health and global health challenges, with therapies that include an oral weekly levomethadone candidate for opioid use disorder (OUD), oral weekly buprenorphine for OUD, a monthly oral contraception pill and oral biweekly ivermectin for malaria eradication. Since the founding of Lyndra, the company’s partners have included the Bill & Melinda Gates Foundation, the NIH, AbbVie and Gilead Sciences, Inc. Lyndra is headquartered in Watertown, MA and has a state-of-the-art GMP manufacturing facility in Lexington, MA. For more information, visit https://lyndra.com
Summary
Lyndra Therapeutics is seeking a Senior Quality Assurance Associate candidate who will report to the Associate Director of Quality Assurance. The individual in this role will maintain on site quality presence during 2nd shift (3-11pm), at Lyndra’s GMP facility in Lexington, MA by providing support for clinical phase manufacturing, batch record review and quality issue resolution. Primary function is to assure the quality of manufactured products is in compliance with all applicable regulations, guidelines, and internal procedures.
Tasks & Responsibilities include
- Proactively promote GMP and compliance concepts.
- Perform quality oversight of clinical phase manufacturing executional compliance with GMP, including QA line clearance, issuance of production batch records, raw material, component, and in-process material release, including CofA review and approval.
- Support batch documentation review and issue resolution (deviations/investigations) for Intermediate and Drug Product (DP) Disposition.
- Support Document Control activities for the Lyndra Document Management System.
- Participate in document life-cycle and training management, such as initiation, document number issuance, document revision, approvals, distributions, and training documentation.
- Perform raw material sampling for QC testing, support Supply Chain with incoming raw material receipt and release.
- Assist in the implementation and migration to electronic Quality Management System (QMS).
- Participate in building and improving all Quality Systems.
- Support in measuring department metrics.
- Assist in preparation of regulatory and partner audits.
Essential Requirements
- Minimum of BA/BS in a science related field
- 2-4 years of related work experience in pharmaceutical or other similar regulated industry
- Working knowledge of Good Manufacturing Practices (GMPs), Good Documentation Practices and application within pharmaceutical development.
- Solid computer skills using MS Word, Excel, PowerPoint, SharePoint and Smartsheet
- Prior experience in using electronic Quality Management System (eQMS) a plus.
- Good organizational, verbal, and technical written communication skills, able to execute multiple tasks.
- Good interpersonal communication skills/able to work in a team environment.
- Able to rapidly adapt to changing environment and circumstances requiring flexibility.
- Ability to troubleshoot and problem solve.