Specialist 2, Quality
Specialist 2, Quality
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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
Additional Details
- Managers Requested Bill Rate : (No Value)
- Purchase Order Number (Contingent) : 1.
- Does the position allow for the worker to be virtual/remote : No
- Drug testing is required for this position : No
- Helix Case ID : IM-
- Program Type : White Collar
Employment Type
Full-time
Key Skills
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