Quality Assurance Associate

Synerfac Technical Staffing

Whippany, NJ

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JOB DETAILS

SKILLS

American National Standards Institute (ANSI), Biology, Biotech and Pharmaceutical, Change Control, Check Processing, Chemistry, Code of Federal Regulations, Communication Skills, Continuous Improvement, Contract Manufacturing, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Detail Oriented, Document Change Management, Document Management, Documentation, Dosage Forms, Establish Priorities, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), ICH Regulations, IP (Internet Protocol), Identify Issues, Internet/IP Telephony, Interpersonal Skills, Maintain Compliance, Manufacturing, Manufacturing Operations, Microsoft Office, Multitasking, Operational Support, Organizational Skills, Problem Solving Skills, Process Management, Process Validation, Product/Service Launch, Production Systems, Quality Assurance, Quality Control, Quality Management, Quality Metrics, Reconciliation, Regulations, Risk Analysis, Root Cause Analysis, SAP, Specimen Collection, Standard Operating Procedures (SOP), System Lifecycle, Team Player, Testing, Time Management

LOCATION

Whippany, NJ

POSTED

20 days ago

Out client is a technology-focused contract manufacturing business with differentiated applications and capabilities in solid, semi-solid and liquid dosage forms, with a particular focus on controlled substances. They have a long-standing commercial relationships with a number of major pharmaceutical companies and maintains facilities in both the United States and Canada.

OVERVIEW
The Quality Assurance Associate (temporary) will provide direct support for a newly launched product manufactured and stick-packed at the site, with a strong focus on shop floor presence and real-time quality oversight. This role is responsible for ensuring daily manufacturing and packaging activities are executed in compliance with cGMPs, approved procedures, and quality standards. Key responsibilities include performing line clearance and in-process checks, supporting batch record review (BRR), managing in-process sampling and testing oversight, and serving as the primary QA point of contact during operations. The associate will triage and support investigations, drive timely CAPA closure and effectiveness, and contribute to continuous improvement of batch records and documentation practices. In addition, the role ensures adherence to QMS processes, verifies material reconciliation and labeling accuracy, and collaborates cross-functionally with Manufacturing, Packaging, and QC teams to maintain compliance, inspection readiness, and a strong quality culture. This position is 100% on site in Whippany, NJ.

RESPONSIBILITIES
QA Inspection

* Provide on-the-floor QA oversight for daily manufacturing and packaging operations ensuring adherence to cGMPs and approved procedures.
* Perform line clearance activities and reviews before and after manufacturing/packaging runs, verifying equipment cleanliness, material status, and absence of mix-up risks.
* Conduct in-process line checks and periodic walkthroughs to confirm compliance with batch records, SOPs, and GMP requirements.
* Review/approve batch records, protocols, and reports for accuracy, completeness and to identify any potential issues. Track, monitor and coordinate batch record lifecycle within Quality system.
* Perform real-time review of batch record entries and execution related supplemental/supporting documents such as logbooks, protocols, and other batch release documents
* Perform sampling of raw materials, packaging components and printed material following SOP, ANSI, CFR, EHS and PMDA guidelines.
* Manage and coordinate in-process (IP) & additional sampling activities, including sample collection, labeling, and submission to QC. Review of C of A or C of C, verify shipments and notify management for discrepancies.
* Provide quality support for on-floor process performance & validation execution and related activity.
* Act as QA point of contact during shop floor execution, providing immediate guidance on deviations, documentation errors, and procedural clarifications.
* Ensure compliance with Quality Management System (QMS) processes, including authoring and reviewing SOPs, deviations, CAPAs, change controls, and document management.

* Identify and drive batch record and documentation improvements to enhance clarity, compliance, and right-first-time execution.
* Triage and support investigations (deviations, OOS/OOT), ensuring timely initiation, accurate documentation, and appropriate escalation.
* Track CAPAs to ensure on-time closure and support effectiveness checks to confirm sustainable resolution of operation issues.
* Verify and maintain compliance over material movement within Quality department through SAP.
* Collaborate closely with Manufacturing, Packaging, and QC teams to support efficient operations while maintaining quality standards.

POSITION QUALIFICATIONS

* Working knowledge of cGMP regulations and guidelines (e.g., FDA, ICH) with practical application in manufacturing and packaging operations.
* Experience performing line clearance, in-process checks, and real-time batch record review in a production environment.
* Familiarity with Batch Record Review (BRR) processes and good documentation practices (GDP).
* Hands-on experience with in-process sampling and/or in-process testing (IPT) coordination or oversight.
* Experience supporting investigations (deviations, OOS/OOT), including documentation, root cause analysis, and follow-up actions.
* Understanding of CAPA and change control processes within a Quality Management System (QMS), including tracking to closure and effectiveness checks.
* Ability to work on the shop floor for extended periods and support a fast-paced manufacturing/packaging environment.
* Strong attention to detail with the ability to identify compliance risks and drive right-first-time execution.
* Effective communication and interpersonal skills, with the ability to collaborate cross-functionally and provide real-time QA guidance to operations teams.
* Strong organizational and time management skills, with the ability to prioritize multiple tasks and meet deadlines.
* Proficiency in standard office software (e.g., Microsoft Office) and familiarity with electronic quality systems (e.g., eQMS, MES) is a plus.
* Flexibility to support non-standard hours, including shift or weekend coverage, as needed.

EDUCATION:
Must have a Bachelor"s degree in scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences) or equivalent combination of education and relevant experience.

EXPERIENCE:
Must have at least 3+ years of experience in a GMP-regulated pharmaceutical, biotechnology, or related manufacturing environment; direct QA shop floor support experience preferred.

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About the Company

Synerfac Technical Staffing

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