Senior Specialist, Quality Assurance

MSD • Rahway, NJ

1d • $106,200 - $167,200 • Hybrid

About The Position

The Senior Specialist, Quality Assurance is accountable for review and approval of documentation to support Good Manufacturing Practice (GMP) clinical supply drug product manufacture, testing, release and maintenance of our Company’s clinical supply programs. They independently perform routine audits of batch documentation, data, information, procedures, equipment and systems, and/or facilities to ensure the compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and other applicable worldwide regulations and our Company procedures. They will also collaborate with the Quality Program Lead to issue reports summarizing results, works with area to ensure resolution of audit findings, and notify relevant management of unresolved issues/trends. The Senior Specialist will become knowledgeable in regulatory requirements, cGMPs and our company procedures to assure clinical drug product manufacture is compliant and will gain competency in their responsibilities. Primary responsibilities include but are not limited to the following: Perform GMP documentation review and approval for internal or outsourced manufacturing of clinical supplies including batch records, deviation and/or out-of-specification approval, change management approval, etc. Support the Quality Program Lead on inter-departmental and cross-functional teams, ensuring communication of accurate information and providing quality guidance and/or deliverables. Accountable for all assigned projects and communication of status to the Management team. Identify need for and/or develop SOPs to ensure practices are accurately reflected. Assist in SOP and quality-related system development and approval. Prioritize work for assigned projects including clinical supply disposition commitments and maintenance of a current GMP posture within Global Development Quality. Adhere to cGMPs and SOPs Identify and implement continuous improvement initiatives and action plans. Assist in preparations for regulatory agency inspections. Ensure procedures are followed and specifications met to release or reject materials. 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 required under GMP. Participate in investigations using root cause analysis techniques, ensure effective corrective actions and preventive actions. Maintain a state of readiness for and participate in audits and inspections. On-site support of production facility & staff (minimum 60% on a weekly basis)

Requirements

• B.S. in appropriate Science or Engineering discipline (chemistry, biology, biochemistry, microbiology).
• 4 years of experience in the pharmaceutical or related industry
• Understanding of current Good Manufacturing Practices (cGMPs) and Good Documentation Practices and related drug regulation requirements, including European Union.
• Experience in one or more functional areas such as quality control, quality assurance, analytical laboratories, manufacturing, production support area, clinical development
• Attention to detail, flexibility, and an awareness of production and associated quality problems.
• Strong interpersonal skills including verbal and written communications, collaboration, teamwork within and across functions, conflict resolution.
• Demonstrated ability to manage multiple projects and priorities simultaneously, and to meet deliverables and timelines.
• Adaptability
• Audits Compliance
• Data Analysis
• Detail-Oriented
• Deviation Management
• Employee Training Programs
• GMP Auditing
• Interpersonal Relationships
• Manufacturing Processes
• Manufacturing Quality Control
• Process Improvements
• Quality Assurance Systems
• Quality Risk Management
• Technical Writing
• Validation Processes

Nice To Haves

• Sterile dosage drug product (vial, syringe, other) manufacturing and/or analytical testing.
• A combination of experiences in quality assurance plus operations, laboratory, or related functional roles. Example functional roles include: quality operations, quality assurance, quality engineering, manufacturing, process engineering, product development, process development, materials management, supply chain management, quality control, analytical development, CMC regulatory affairs, equipment or facilities management.
• Diverse experiences in a GMP environment including but not limited to batch production record development, review, or approval, ancillary batch related records, standard operating procedures, work instructions, raw materials, deviations, change control, corrective actions, preventive actions, out of specification results, cleaning, validation plans or protocols, equipment qualification, audits, electronic inventory systems, quality management systems.
• Ability to identify, focus, and solve problems in a timely and efficient manner.
• Experience with quality audits and EU regulatory inspections.
• Experience or working knowledge of R&D or clinical supply areas and processes.
• 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 Employment Opportunity 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
• 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 applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
• Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Responsibilities

• Perform GMP documentation review and approval for internal or outsourced manufacturing of clinical supplies including batch records, deviation and/or out-of-specification approval, change management approval, etc.
• Support the Quality Program Lead on inter-departmental and cross-functional teams, ensuring communication of accurate information and providing quality guidance and/or deliverables.
• Accountable for all assigned projects and communication of status to the Management team.
• Identify need for and/or develop SOPs to ensure practices are accurately reflected.
• Assist in SOP and quality-related system development and approval.
• Prioritize work for assigned projects including clinical supply disposition commitments and maintenance of a current GMP posture within Global Development Quality.
• Adhere to cGMPs and SOPs
• Identify and implement continuous improvement initiatives and action plans.
• Assist in preparations for regulatory agency inspections.
• Ensure procedures are followed and specifications met to release or reject materials.
• 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 required under GMP.
• Participate in investigations using root cause analysis techniques, ensure effective corrective actions and preventive actions.
• Maintain a state of readiness for and participate in audits and inspections.
• On-site support of production facility & staff (minimum 60% on a weekly basis)

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Senior