Specialist, Quality Assurance - Hybrid

Merck • Rahway, NJ

332d • $85,600 - $134,800

About The Position

The 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. This person will also review and approve documentation accompanying the disposition of excipients, components, and critical supply items for sterile or non-sterile use to ensure conformance to appropriate regulatory and company requirements for clinical supply manufacture and/or regulatory inspections. Independently performs 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. Collaborates with the Quality Program Lead to issue reports summarizing results, works with area to ensure resolution of audit findings, and notifies relevant management of unresolved issues/trends. The Specialist will become knowledgeable in regulatory requirements, cGMPs and our Company procedures to assure clinical drug product manufacture is in compliance and will gain competency in their responsibilities.

Requirements

• B.S. in appropriate Science or Engineering discipline (chemistry, biology biochemistry, microbiology).
• Two years of experience in a GMP environment and executing against Good Documentation Practices and related drug regulation requirements, including European Union.
• Evidence of good oral and written communication skills, i.e., effective presentation of concepts and ideas, interpersonal and conflict resolution skills.
• Ability to manage multiple priorities and projects simultaneously.
• Attention to detail, flexibility, and an awareness of production and associated quality problems.

Nice To Haves

• Experience in Pharmaceutical or related industry in quality control, quality assurance, manufacturing, clinical development or clinical supply areas.
• Excipients and components release requirements/testing.
• Non-sterile and/or sterile drug product manufacture/testing.
• Knowledge of SAP.
• Problem-solving skills.

Responsibilities

• Perform GMP review of in-coming material documentation and disposition for use in clinical supplies including vendor provided documentation, incoming inspection packet, deviations and change management records, etc.
• 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.

Benefits

• Bonus eligibility
• Long term incentive if applicable
• Health care and other insurance benefits (for employee and family)
• Retirement benefits
• Paid holidays
• Vacation
• Sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree