[ref. b25219516] Northbridge - Lead Quality Assurance Operations

Overview:

Be Seen and Heard at EyePoint Pharmaceuticals

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
• transforming ocular drug delivery

We See You.

Your wellbeing

Your professional worth

Your future at EyePoint

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.

This role is responsible for providing routine on-the-floor QA presence and oversight to the manufacturing operation. This role will include identifying compliance risks in the operation prior to and during execution, avoiding deviation whenever possible as well as managing immediate corrective action.

This position is reporting to the Manager, QA Operations and is located at our Northbridge, MA facility, with occasional travel to our Watertown, MA site. This is an on-site role that directly supports the manufacturing production schedule. Flexibile work hours/logistics will be dependent on manufacturing production schedule.

Responsibilities:

Primary responsibilities include, but are not limited to, the following:

Individual responsibilities

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. Special focus on API/Drug Subtance manufacturing batch records and QC analytical data review.

Review and approve GMP documentation against SOPs (Standard Operations Procedures) 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, elevating only those issues that require buy-in from department Leadership.

Partner with Manufacturing Operations to meet schedule requirements and resolve challenges.

Manage process control data (standard control charts).

Review and approve and support timely closure of Quality Systems (Change Controls, CAPAs, Deviations, Non-Conforming Materials, gap analyses, and product complaints)

Qualifications:

Primary skills and knowledge required include, but are not limited to the following:

Proficient knowledge of CGMP, with a focus on API/Drug Substance and QC analytical data review

Experience performing visual and mechanical inspections using AQL Sampling Plans.

Ability to make sound compliance-related decisions with minimal supervision.

Must possess strong attention to detail.

Ability to navigate computerized programs such as MasterControl (Document Management System) 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.

Level of Education Required:

Associate’s OR Bachelor’s degree in relevant field.

Number of Years of Experience in the Function and in the Industry:

At least 5 years of CGMP experience required; QA/QC role preferred.

On the job experience will be considered in lieu of education requirements.

Envision Your Future

With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics.

• Success begins with our People
• Patients First
• Integrity
• Results-Driven
• Innovation
• Team Focus
• Diversity & Inclusion

All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

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