QA Documentation Specialist

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.

The Quality Assurance Documentation Specialist will report into the Sr. Lead Trainer/Supervisor DMT and will be performing a wide variety of activities pertaining to assuring quality and compliance in adherence to applicable Regulatory requirements and company’s quality policies.

This position is located at our Watertown, MA location. We offer a hybrid work schedule.

The Documentation Specialist position will maintain the Quality Standards of the company’s products or services by ensuring adherence to company policies, Regulatory guidance, and client specific requirements.

Assist in all aspects of Quality in respect to clinical trial materials and commercial products as required. This position provides Quality Assurance support to the Development, Operations, Quality Engineering/Quality Control, and Regulatory Affairs departments.

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

Individual responsibilities

This role’s primary focus will be to control and manage documents through the Electronic Quality Management System (eQMS) and Quality Management System process. The Documentation Specialist will work with department authors to edit, format, illustrate, update, and create new standard operating procedures and other related documentation to include, but not limited to: master batch records, logbooks, and other technical documentation in support of cGMP. The Documentation Specialist will support internal and external audits/inspections and support the Quality Management Review process.

• Coordinates the revision process of controlled documentation in eQMS AssurX. 
• Implements and maintains quality systems, policies and procedures that ensure compliance to cGMP, FDA (i.e. 21CFR11, 820, 210, 211) and other regulatory standards.
• Assists in organizing and tracking QA records and scanning, archiving, maintain historical files for controlled documentation.
• Enters, updates, and edits-controlled documents and coordinate requirements for new documents with internal customers.
• Controls and issues logbooks and laboratory notebooks.
• Controls and issues batch production records and QC testing data packets in support of manufacturing.
• Finalize and publish working documents to include: SOPs, WIs, batch records etc. for use by Production.
• Control distribution and monitor workflow of controlled documents and maintain document database on Revised and distributed SOPs.
• Issue controlled documents for training, testing, or batch production
• Support implementation of Quality System Improvements with Management’s guidance in moderate technical problem solving within function and/or cross-functional areas.
• Execute validation test scripts in support of computer system
• Participates in inspection readiness activities.  During inspections, may interact with regulatory inspectors regarding training and document management policies, procedures, and documentation.
• Routinely provide input to quality and operations management for better operational procedures to improve overall efficiency and regulatory compliance.
• Perform duties regarding special projects, as assigned by QA Management.

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

• Background and demonstrated effectiveness in Quality Systems as they relate to Document Control and compliance of commercial medical device / pharmaceutical in an FDA regulated environment.
• Proficient in Document Management Systems (AssurX) and document formatting/word processing
• Demonstrated ability in performing document coordination and archival activities
• Demonstrated ability in managing tracking databases and logs
• Strong internal customer service/people skills are required.
• Ability to present self in a professional, credible manner and communicate effectively at all levels of the organization.
• Positive attitude, self-motivated, strong work ethic, organizational skills, communication skills, critical thinking, attention to detail and accuracy, the ability to work independently and in a team environment, are essential.
• Excellent professional verbal, written, and communication skills.
• Capable of timely completing assigned responsibilities under supervision where required and keeping Manager informed of status.
• Ability to prioritize and organize own work, multi-task, meet deadlines and keep commitments.
• Flexible and able to respond quickly to shifting priorities and meet deadlines.
• Works under supervision where required and follows established procedures along with own judgment.
• Capable of developing innovative/creative solutions to issues of normal
• Proficiency with Microsoft Office tools and other office (Excel, Word, PowerPoint, Outlook).

Level of Education Required:

• Certificate or associate’s degree in science OR an equivalent combination of education and experience.

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

• 3 years of demonstrated practical Quality Systems or Quality Documentation Control or Quality Assurance experience directly related to position responsibilities.
• Working knowledge of FDA/EU regulatory requirements applicable to pharmaceutical drug products. Ability to apply cGMP regulations to all aspects of the position.
• Understanding of Quality concepts/requirements and be able to practice and implement them.
• General understanding of GMP manufacturing processes and drug products.
• Electronic Documentation Management System (EDMS). AssurX preferred.
• Strong working knowledge of Microsoft Office products. Technical writing 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.

The collective power of our values influences everything we do, and everything we do for you.

Transformational Innovation

We exist to change our patients’ lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology.

Unwavering Integrity

We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us.

Compassionate Excellence

We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes.

Inclusive Collaboration

We strive to see through the eyes of others and work as one team. We appreciate one another’s differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward.

EyePoint Pharmaceuticals is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. 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.