Specialist 2, Quality
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Job Location:
Summit, WA - USA
Monthly Salary:
Not Disclosed
Posted on:
13-08-2025
Vacancies:
1 Vacancy
Job Summary
Position Details:
Our client a world-leading Pharmaceutical Company in Summit NJ is currently looking for an Quality Documentation Specialist to join their expanding team.
Job Title: Quality Documentation Specialist / Pharma-Consumer Products
Duration: 17 months contract extendable up to 24 months
Location: Summit NJ
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Our client a world-leading Pharmaceutical Company in Summit NJ is currently looking for an Quality Documentation Specialist to join their expanding team.
Job Title: Quality Documentation Specialist / Pharma-Consumer Products
Duration: 17 months contract extendable up to 24 months
Location: Summit NJ
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
The Specialist R&D Quality & Compliance (R&D Q&C) is responsible for the administration of integrated and comprehensive quality systems and controls that are appropriate effective efficient and continuously improving in order to ensure that R&D functions are operating in full compliance with sound scientific practice Current Good Manufacturing Practices (CGMP) and within Kenvue policies and Standard Operating Procedures.
The Specialist is responsible for participating on documentation quality review/approval of R&D Sales Samples and R&D Product Quality Complaints (PQCs).
The Specialist is responsible for participating on documentation quality review/approval of R&D Sales Samples and R&D Product Quality Complaints (PQCs).
In addition to these tasks supporting documentation maintenance and archival quality inspections of R&D products and in internal assessments on R&D processes specific to GxP.
The Specialist must be knowledgeable to provide guidance on applicable Regulations (FDA ICH EU and others) pertaining to business partners.
Principal Responsibilities:
Participate in GMP documentation review and approval of sales samples including identifying opportunities to optimize release processes for agility and speed to customer sales teams.
Participate in working with various functional groups as needed to conduct problem identification and resolution along with assisting in compiling documentation to review and approve assessments and/or investigations for R&D Product Quality Complaints (PQC).
Support in the development and implementation of GMP and Quality & Compliance processes and procedures including supporting GMP documentation review and approval.
Support on internal assessments of R&D GMP processes and areas and identify opportunities to streamline.
Support in inspection readiness activities.
Support quality inspection of supplies for R&D studies.
Desired Qualifications
Experience of the overall product development process
Problem solver (proactive in providing and executing solutions)
Knowledge of procedures governing R&D GMP Analytical/Micro and GLP activities
Working knowledge of applicable regulatory requirements (cGMPs and cGLPs) governing various
product classification types (cosmetic OTC/OTC Monograph and Medical Devices)
Ability to Independently plan organize co-ordinate manage and execute assigned tasks
Ability to work collaboratively in team environments
Written and oral proficiency in the English language
Strong communicator with excellent interpersonal skills and diplomacy
Good conflict handling/negotiation skills
Participate in GMP documentation review and approval of sales samples including identifying opportunities to optimize release processes for agility and speed to customer sales teams.
Participate in working with various functional groups as needed to conduct problem identification and resolution along with assisting in compiling documentation to review and approve assessments and/or investigations for R&D Product Quality Complaints (PQC).
Support in the development and implementation of GMP and Quality & Compliance processes and procedures including supporting GMP documentation review and approval.
Support on internal assessments of R&D GMP processes and areas and identify opportunities to streamline.
Support in inspection readiness activities.
Support quality inspection of supplies for R&D studies.
Desired Qualifications
Experience of the overall product development process
Problem solver (proactive in providing and executing solutions)
Knowledge of procedures governing R&D GMP Analytical/Micro and GLP activities
Working knowledge of applicable regulatory requirements (cGMPs and cGLPs) governing various
product classification types (cosmetic OTC/OTC Monograph and Medical Devices)
Ability to Independently plan organize co-ordinate manage and execute assigned tasks
Ability to work collaboratively in team environments
Written and oral proficiency in the English language
Strong communicator with excellent interpersonal skills and diplomacy
Good conflict handling/negotiation skills
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
