Quality Control Inspector I (Technician)

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 person will report directly to the Quality Control Manager and will be responsible for all aspects of quality control in respect to clinical trial materials and commercial products as required. This position provides production support for incoming, in process production and final product test and inspection.

The individual will work in the GMP Incoming Quality room to ensure that all Raw Materials are tested, as well as all Final Product testing that is performed by CTOs. That all test results are approved for release in accordance to all applicable GMP regulations and guidelines (e.g. 21CFR Parts 11, 210/211, 820, (USP/EP/JP), ICH Guidelines), as well as company’s procedures.

This position is located at our Northbridge, MA site.

Responsibilities:

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

Individual responsibilities

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

• Perform sample management and inspection quality assurance (IQA) of raw materials, components, in-process production and final product, as required.
• Maintain inspection data trend charts as well as chart recorder records.
• Adhere to the GMP Quality Management System (QMS) to ensure compliance with documented policies, procedures and work instructions.
• Identify IQA anomalies and/or discrepancies then escalate to QC Manager in a timely manner
• Provide support for investigations regarding deviations, out-of-trend (OOT)/out-of-specification (OOS) results, Material Evaluation Reports or Environmental Alert/Action Report (EAR).
• Use SOPs, WIs, Specifications, Trends, other applicable references and expertise to propose solution(s) to QC inspection issues.
• Provide QC inspection support for protocols and reports as appropriate.
• Plan and perform workload to meet schedules, timelines, deadlines as per procedure’s and/or department requirements.
• Participate in group and/or project teamwork for project and process improvements.
• Support internal and external audits and regulatory inspections, as required.
• Identify gaps in systems and procedures. Review proposed changes to systems, procedures, methods, as appropriate.
• Quality assurance activities as required including but not limited to line clearance and production inspection.
• Participate as Subject Matter Expert (SME) during Regulatory Inspections, as appropriate.
• Perform visual and dimensional inspections of raw materials utilizing equipment such as microscopes, calipers, micrometers.

Qualifications:

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

• Previous GMP experience or other regulated industry is required.
• Must have the ability and skill to perform the detailed job requirements noted above competently, safely and proficiently.
• Self-starting motivated person who possesses good interpersonal skills and who is able to effectively interact with all departments with the Company.
• Must have good organizational and verbal communication skills.
• Adept at using Microsoft Office Products.
• Must be a team player with integrity and concern for the quality of Company products, services and staff members.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Ability to lift up to 50 lbs. on occasion.

Ability to work on your feet in a classified clean room environment for up to 5 hours per day

Level of Education Required:

Technical High School Diploma

Preferred Field of Study: ASQ Certified Quality Technician (CQT) certification is a plus

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

Two years of GMP or other regulated industry experience

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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