Senior Specialist, Quality Assurance, Sterile Quality - Hybrid

Merck•Rahway, NJ

8d•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. Essential Duties and Responsibilities: The Specialist will become knowledgeable in regulatory requirements, cGMPs and 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:

Requirements

B.S. in appropriate Science or Engineering discipline (chemistry, biology, biochemistry, microbiology).
5 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.
Must be able to work on first and second shift.

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.
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.

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)