EyePoint
Base pay range
$92,000.00/yr - $116,000.00/yr 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 Drug Product / Combination Product aspects of the MFG process/batch records. 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). 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). Qualifications
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 (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. Education & Experience
Associates OR Bachelors degree in relevant field. At least 5 years of CGMP experience required; QA/QC role preferred. On the job experience will be considered in lieu of education requirements. Job Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance EyePoint is an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success, 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 regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoints compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity. #J-18808-Ljbffr
$92,000.00/yr - $116,000.00/yr 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 Drug Product / Combination Product aspects of the MFG process/batch records. 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). 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). Qualifications
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 (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. Education & Experience
Associates OR Bachelors degree in relevant field. At least 5 years of CGMP experience required; QA/QC role preferred. On the job experience will be considered in lieu of education requirements. Job Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance EyePoint is an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success, 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 regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoints compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity. #J-18808-Ljbffr