Senior Specialist, Quality Assurance (Hybrid)

Job description

Job Description Job Description: The Rahway based Senior Specialist, Global Development Quality Operations – API, is responsible for independent approval of documentation to support Good Manufacturing Practice (GMP) clinical supply API manufacture, testing, release, and maintenance in support of our company's clinical supply programs. This person will also independently approve documentation accompanying the disposition of API materials to ensure conformance to appropriate regulatory and company requirements. In support of clinical supply manufacture and/or inspections independently perform or coordinate routine and specialized audits of audits of batch documentation, data, information, procedures, equipment and systems, and/or facilities to ensure compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and other applicable worldwide regulations and our Company's requirements. Primary responsibilities include but are not limited to the following: Perform quality assurance activities related to API manufacturing in a complex, clinical supply development. Review and/or approve GMP documents. Ensure all API manufactured in compliance with cGMP and regulatory filings. Perform independent quality review and approval of batch records, testing data, and related documents required to release or reject product. Make independent batch release or reject decisions. Conduct independent auditing, review, and approval of diverse and complex document types, as required, including deviations, investigations, change records, analytical method validations, method transfers, analytical methods, specifications, certificates of analysis, etc. Accountable for all assigned projects and communication of status to the Management Team. Build collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality assurance, regulatory, etc. at all levels. Establish, educate, and enforce standard operating procedures (SOPs) required under GMP. Develop/update SOPs to ensure practices are accurately reflected. Assist in SOP and quality-related system document approval. Support metrics by summarizing findings during documentation reviews. Collect, prepare and analyze data to support quality system metrics and planning. Support compliance activities such as site readiness, audits, inspections, and CAPAs. Support quality risk management activities as facilitator, project lead and/or quality subject matter expert. Proactively identify, execute and manage independent projects for continuous quality improvement and efficiency. Support the implementation of the clinical supply QMS through participation as topic team member and/or subject matter expert. Represent Development Quality on inter-departmental and cross-functional teams, ensuring communication of information and providing quality guidance and/or deliverables. Exercise broad judgment in making quality decisions and solving complex problems. Escalate issues as needed. Provide meeting coordination, facilitation, scribing, and communication. Other duties as assigned by manager for the flexible functioning of the work group. Education Minimum Requirements: Bachelor degree (B.S.) in an appropriate Science or Engineering discipline (engineering, chemistry, biology, biochemistry, microbiology). Minimum of 5 years’ experience with a B.S. Required Experience and Skills: Experience in the pharmaceutical or closely related industry. Experience in one or more functional areas such as quality assurance, analytical laboratories, manufacturing, production support area, equipment/facilities management, regulatory. GMP or related drug regulation knowledge and expertise. Strong leadership, collaboration, teamwork, negotiation, communication, problem-solving and workload management skills. Excellent verbal and written communication including presentation skills. Demonstrated ability to manage projects, priorities, to meet deliverables and timelines. Attention to detail, flexibility, and an awareness of production and associated quality problems. Ability to work in a dynamic environment with rapidly changing needs. Ability to work across functional and sites, with all levels of staff and management. Qualified candidates should have proficiency with Microsoft Suite (Word, Excel, PowerPoint, Teams, etc.) and ability to adapt to learning other electronic systems to support day-to-day work. Preferred Experience and Skills: Experience in small molecule API manufacture/testing. Small molecule API knowledge and experience. Knowledge of R&D or clinical supply areas and processes. Experience with manufacturing and analytical investigations and CAPAs. System knowledge of Veeva, SAP. Required Skills: Audits Compliance, Data Analysis, Deviation Management, GMP Auditing, GMP Compliance, Good Manufacturing Practices (GMP), Process Improvements, Project Management, Quality Assurance (QA), Standard Operating Procedure (SOP), Systematic Problem Solving, Technical Writing Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $106,200.00 - $167,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits. You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified appli