Overview
FSQA Tech I – Days – Lab Jobs in Conway, AR at Westrock Coffee
At Viridian Therapeutics, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-driven decisions, thoughtful risk-taking, and efficient use of time and funds to best position our ideas for success. We value thoughtful ideas, open communication, and transparency, and are committed to a culture that allows employees to contribute at a high level, grow their careers, and balance their personal and professional ambitions.
This a dynamic role with a diverse set of responsibilities. Reporting to the Associate Director of Quality Control, the Manager, Quality Control, Tech Services, will primarily provide oversight of Viridian’s testing program performed by outside testing laboratories. The QC Manager will review method validation at CMO/CTL, manage change and investigations, and manage release data from CMO/CTL. This position works closely with other functions within Viridian and external CMO/CTLs.
This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week.
Responsibilities (including, but not limited to):
Review method qualification/validation protocols and reports. Review sampling protocols
Manage release data across multiple programs through data review, trending, and generation of CoAs
Drive change controls including specification changes and method changes
Author and manage OOS investigations and Deviations. Troubleshoot issues and drive resolutions
Collaborate with internal stakeholders and CMO/CTLs for QC testing-related topics to ensure compliance and timeliness
Perform trend analysis including testing data to support specifications for clinical and commercial drug substance and drug products and prepare the reports. Trend assay control parameters
Write, revise and review Quality Control SOPs
Track and trend reference materials. Review reference standard protocols and reports
Author CMC sections for regulatory filings
Assist in Audits with QA
Perform other duties as required
Qualifications:
7+ years of relevant experience
Bachelor’s degree required
Master’s degree preferred with 5+ years’ experience
Thorough knowledge of GMP testing requirements, including Analytical Life Cycle
Experience managing a CMO/CTLs
Experience with technical writing for regulatory CMC sections
Well versed in various analytical and bioanalytical techniques (e.g., ELISAs, spectroscopy, HPLC, UPLC, electrophoresis, compendial and other methods for biopharmaceuticals). Preference for chromatography experience
Working knowledge of quality systems and regulatory requirements (ICH and 21CFR Part 11/210/211, 820)
Experience identifying, evaluating, and closing change controls, OOS’s and investigations
Experience with Veeva eDMS, LIMS software, statistical software, and Smartsheet preferred
Strong commitment to ethical standards
Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
Ability to travel up to 5%
The salary range for this position is commensurate with experience
Viridian offers a comprehensive benefits package including:
Competitive pay and stock options for all employees
Medical, dental, and vision coverage with 100% of premiums paid by Viridian for employees and their eligible dependents
Fertility and mental health programs
Short- and long-term disability coverage
Life, Travel and AD&D
401(k) Company Match with immediate company vest
Employee Stock Purchase plan
Generous vacation plan and paid company holiday shutdowns
Various mental, financial, and proactive physical health programs covered by Viridian
Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.
Title: FSQA Tech I – Days – Lab
Company: Westrock Coffee
Location: Conway, AR
