EyePoint Pharmaceuticals, Inc. Quality Assurance Document Control Associate/Specialist in Watertown, Massachusetts
We are looking for two Quality Assurance Document Control Associate/Specialists at EyePoint Pharmaceuticals!
We are an ophthalmology focused company committed to developing and commercializing innovative ophthalmic products in indications with high unmet medical need to improve the lives of patients with serious eye disorders
EyePoint Company Values include:
Success begins with our People – our employees are valued, relied upon and key to our company’s success
Patient First – above all, we dedicate our skills, actions & resources to achieve quality outcomes for our patients
Integrity– we are always honest, open, ethical and fair
Results-Driven– we are decisive and act with a sense of urgency against clear and aggressive goals
Innovation – we strive for continuous improvement through thoughtful risk-taking
Team Focus– we work and communicate in a collaborative, respectful and inclusive fashion
Diversity & Inclusion - We commit to diversity in our staff and embrace inclusion and acceptance of others without bias
The Quality Assurance Document Control Associate/Specialist 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. Activities include but are not limited to: review of GMP raw data for compliance, review of GMP documentation to support batch disposition, review/approval of GMP procedures, protocols and reports, Quality Management Systems-related training, identifying gaps in existing quality systems and propose solutions to quality management.
The Quality Assurance Document Control Associate/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. The QA Associate I may participate in internal audits; assess and approve deviations, change controls, etc., and will also support quality management for activities related to training of employees.
Assist in all aspects of quality in respect to clinical trial materials and commercial products as required. This position provides quality support to the development, operations, quality and regulatory affairs departments.
Primary responsibilities include, but are not limited to, the following:
Perform review and approval of batch related documentation (cGMP procedures, manufacturing batch records, solution records, test data and certificates, protocols and reports, etc.) to support product disposition.
Perform documentation coordinator activities to provide assurance that SOPs, test methods, raw materials, external testing and forms, specifications and other documentation are reviewed, approved and archived in a timely manner.
Assist quality management in additional responsibilities related to day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, and ensure the safety, efficacy and purity of the products manufactured by EyePoint Pharma (e.g. batch record review, etc.).
Support and track until completion of quality compliance activities such as deviation's investigation process (i.e. investigation support of root cause analysis/impact assessment), change control, technical memos, regulatory documents and commitments, etc.
Support resolution of both technical and compliance issues/gaps of moderate complexity.
Support implementation of Quality Management System improvements with management's guidance in moderate technical problem solving within function and/or cross functional areas.
Identify potential compliance issues and opportunities for improvement to the overall quality system. Assist in the implementation of process improvement to enhance compliance and improve method and product quality process (e.g. process tools creation, SOP revision, or enterprise systems implementation).
Support site training initiatives by participating in new employee orientation activities, uploading of courses into electronic training system.
Participate in regulatory inspection and internal audit, as required.
Perform duties regarding special projects, as assigned by quality management.
Primary skills and knowledge required include, but are not limited to the following:
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.
Good verbal and written communication skills.
Capable of timely completing assigned responsibilities under minimal supervision and keeping quality manager informed of status.
Flexible and able to respond quickly to shifting priorities and meet deadlines.
Routinely exercises sound judgment, reasoning and problem solving. Must be able to deal with
Capable of developing innovative/creative solutions to issues of moderate complexity.
Proficiency with Microsoft Office tools (Excel, Word, PowerPoint, Outlook).
Ability to work and interact with all departments at EyePoint Pharma.
Ability to communicate and work independently with scientific/technical personnel in both internal and external setting.
General understanding and knowledge of relevant US FDA and EU EMA regulations.
General understanding of quality concepts/requirements and be able to practice and implement them.
General understanding of the manufacturing process.
Knowledge of SABA training software is a plus.
Level of Education Required/Preferred Field of Study:
- BS/BA in science or an equivalent combination of education and experience in related field of pharmaceutical biopharmaceutical industry
Number of Years of Experience in the Function and in the Industry:
- 1-2+ years of demonstrated practical Quality Assurance Document Control experience directly related to position responsibilities.
External Company Name: EyePoint Pharmaceuticals, Inc.
External Company URL: http://eyepointpharma.com/
Street: 480 Pleasant Street