Lead Quality Assurance Operations

Eyepoint Pharmaceuticals-posted 3 months ago
$92,000 - $116,000/Yr
Hybrid • Northbridge, MA
Chemical Manufacturing
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At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we're taking in business fuels our success for preventing blindness through vision-saving medications, delivering best-in-class proprietary pharmaceutical technologies, and transforming ocular drug delivery. EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There's space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected.

  • Perform QA on-the-floor batch record review responsibilities including in-process batch record review, execution of QA walkthroughs, performance of line clearance, and in-process / final product inspections.
  • Review and approve GMP documentation against SOPs to ensure manufacturing steps are appropriately documented, observations are clear, and Good Documentation Practices are followed.
  • Conduct GMP area in-process audits and walkthroughs of GMP area(s) for detection of non-compliance issues, inspection risks, and procedural or GMP non-compliances.
  • Perform assessments by collecting and analyzing accurate, objective evidence regarding risks and their magnitude.
  • Represent QA in meetings or on project teams, exercising broad authority in decision making and commitments on behalf of QA.
  • Partner with Manufacturing Operations to meet schedule requirements and resolve challenges.
  • Manage process control data (standard control charts).
  • Perform and support individuals and teams through root cause analysis investigations.
  • Review and approve and support timely closure of Quality Systems (Change Controls, CAPAs, Deviations, Non-Conforming Materials, gap analyses, and product complaints).
  • Proficient knowledge of cGMP, with a focus on Drug Product / Combination Product aspects of the MFG process/batch records.
  • Ability to make sound compliance-related decisions with minimal supervision.
  • Must possess strong attention to detail.
  • Ability to navigate computerized programs such as AssurX and ERP Systems.
  • Strong communication (written and verbal) and organizational skills.
  • Ability to independently manage multiple priorities in a dynamic environment.
  • High level of personal/departmental accountability and responsibility.
  • Creatively use business concepts and company policies/procedures to solve problems.
  • Excellent complex problem-solving and teamwork skills.
  • Proficient at resolving issues in creative and innovative ways.
  • Exercises good judgment in selecting methods/techniques to achieve positive results.
  • Combination Product experience is a plus.
  • Statistical Process Control (SPC) data entry and out of control resolution experience is a plus.
  • Competitive salary range of USD $92,000.00 to $116,000.00 per year.
  • Robust total rewards package.
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