Specialist, Quality Assurance
Princeton, New Jersey, United States
Job Summary
Occupation
Healthcare-Quality Control/Quality Assurance
Specialty
Quality Assurance Specialist
Location
East Windsor, New Jersey, New Jersey, United States
Visa Sponsorship
No
Job Description
Last Update:
1/11/24
The Quality Assurance Specialist is responsible for reviewing Batch records, specifications, procedures, protocols, and records for GMP compliance. Responsibilities also include GMP audits of the plant, coordinate and track closeouts of deviations, change control requests, consumer complaints, and out-of-specification investigations.
Primary Duties & Responsibilities:
Review raw material, packaging material, in-process material, and finished product specifications for GMP compliance û Reconciliation of OTC Batch Records.
Prepare master production records for all OTC products if assigned.
Perform review of batch production and control records for OTC products and initiate investigation for any unexplained discrepancy found during review. Prepare Certificate of Manufacturing and Compliance and release OTC products for shipment.
Provide assistance writing OOS, Consumer complaint investigation, metrics reports. Present data through meetings and as written documents. Propose appropriate CAPAs to avoid reoccurrences.
File and maintain batch production and control records for OTC product.
Conduct Annual Product Review of OTC products. Approve the BOMs, review CRAs
Administers CAPA system focusing on CAPA approval, closure and database tracking.
Conduct Internal Quality Audits. Report observations and other potential concerns to the auditees and management, both through verbal presentation and written audit reports.
Coordinate and track completion of action items generated due to deviations and change control requests
Provide GMP Training to other departments as needed
Researches and prepares data needed for monthly quality metrics reporting
Assist in any project/task assigned by the Manager.
Qualifications:
Bachelor's degree (B. A.) from four-year College or university preferably with a Engineering or Science major.
Two years knowledge of pharmaceutical GMP documentation requirements and quality assurance experience in a regulated industry.
Good understanding of 21CFR (Part210-211), ICH guidelines
Expert in Excel and PowerPoint presentation.
Good presentation skills.
Excellent demonstration of verbal and written communication skill
Competencies:
Our Principles serve as the working principles that every Shiseido employee must follow. These eight working principles û known as ôTRUST 8ö û are based on the idea that mutual trust is the key to succeeding in Our Mission.
THINK BIG û Adapt a big-picture perspective. Deliver new values through creativity.
TAKE RISKS û Embrace risk. Practice ôTrial & Error & Trialö.
HANDS ON û Consider front-line realities when making decisions. Take the lead from end-to-end.
COLLABORATE û Break free from the silo mentality. Leverage the diverse capabilities of colleagues.
BE OPEN û Be transparent. Create an environment that encourages everyone to speak up û even if it is bad news.
ACT WITH INTEGRITY û Be sincere and humble at all times.
BE ACCOUNTABLE û Commit to the goal. Take accountability for the execution.
APPLAUD SUCCESS û Create a culture that celebrates success.
Shiseido is an Equal Opportunity Employer and does not discriminate on the basis of race, color, gender identity, religion, sex, age, national origin, disability, veteran status, sexual orientation, genetic information or any other classification protected by Federal, State or Local law
Primary Duties & Responsibilities:
Review raw material, packaging material, in-process material, and finished product specifications for GMP compliance û Reconciliation of OTC Batch Records.
Prepare master production records for all OTC products if assigned.
Perform review of batch production and control records for OTC products and initiate investigation for any unexplained discrepancy found during review. Prepare Certificate of Manufacturing and Compliance and release OTC products for shipment.
Provide assistance writing OOS, Consumer complaint investigation, metrics reports. Present data through meetings and as written documents. Propose appropriate CAPAs to avoid reoccurrences.
File and maintain batch production and control records for OTC product.
Conduct Annual Product Review of OTC products. Approve the BOMs, review CRAs
Administers CAPA system focusing on CAPA approval, closure and database tracking.
Conduct Internal Quality Audits. Report observations and other potential concerns to the auditees and management, both through verbal presentation and written audit reports.
Coordinate and track completion of action items generated due to deviations and change control requests
Provide GMP Training to other departments as needed
Researches and prepares data needed for monthly quality metrics reporting
Assist in any project/task assigned by the Manager.
Qualifications:
Bachelor's degree (B. A.) from four-year College or university preferably with a Engineering or Science major.
Two years knowledge of pharmaceutical GMP documentation requirements and quality assurance experience in a regulated industry.
Good understanding of 21CFR (Part210-211), ICH guidelines
Expert in Excel and PowerPoint presentation.
Good presentation skills.
Excellent demonstration of verbal and written communication skill
Competencies:
Our Principles serve as the working principles that every Shiseido employee must follow. These eight working principles û known as ôTRUST 8ö û are based on the idea that mutual trust is the key to succeeding in Our Mission.
THINK BIG û Adapt a big-picture perspective. Deliver new values through creativity.
TAKE RISKS û Embrace risk. Practice ôTrial & Error & Trialö.
HANDS ON û Consider front-line realities when making decisions. Take the lead from end-to-end.
COLLABORATE û Break free from the silo mentality. Leverage the diverse capabilities of colleagues.
BE OPEN û Be transparent. Create an environment that encourages everyone to speak up û even if it is bad news.
ACT WITH INTEGRITY û Be sincere and humble at all times.
BE ACCOUNTABLE û Commit to the goal. Take accountability for the execution.
APPLAUD SUCCESS û Create a culture that celebrates success.
Shiseido is an Equal Opportunity Employer and does not discriminate on the basis of race, color, gender identity, religion, sex, age, national origin, disability, veteran status, sexual orientation, genetic information or any other classification protected by Federal, State or Local law