Sr QA Scientist

Posted on Nov 17, 2018 by Affinity Executive Search

High Point, NC 27260
Research & Development
Immediate Start
Annual Salary
Full-Time
We are currently accepting resumes for the position of Sr. Quality Assurance Scientist.

Purpose
The Sr. QA Scientist is an advanced level position with hands-on QA experience in a pharmaceutical environment. Working independently and under minimum supervision, the individual will be working primarily to support to Manufacturing operations. The Sr. QA Scientist, will assure products are manufactured in compliance with internal, regulatory and industry standards, meets business needs and optimizes cost in the quality organization of the manufacturing facility.

Responsibilities

* Perform a wide variety of quality assurance activities to ensure compliance with internal procedures, applicable US regulatory requirements, and customer requirements for drug substances under clinical development
* Review and may approve documents such as standard operating procedures, manufacturing batch records, packaging and labeling records, test methods, specifications, stability protocols and reports
* Review executed production batch records and associated documentation including any deviation and investigation reports related to lot release
* Act as a compliance resource to provide guidance and assistance towards resolution of simple to moderate deviations, quality investigations, CAPAs and change control; review and may approve quality system documents related to manufactured products
* Perform product complaints investigations
* Ensure compliance with company policies and SOPs as well as FDA and other applicable guidelines.
* Assist with hosting and responding to client audits
* Assist with developing and maintaining companys quality system
* Support continuous improvement of quality systems; author new, revise existing and may review department procedures and/or forms
* Support quality systems, as needed (e.g., issue and track closure to change controls, deviations, quality investigations, CAPAs)
* Assist with inspection preparation and inspection strategy room for regulatory agency inspection or third party audits
* Serve as a backup to Senior Document Control Specialist, Associate Quality Assurance Scientist and Sr. Quality Assurance Scientist
* In the absence of the Director, Quality Assurance provide guidance to the QA department.
* Other duties as assigned and / or developed by Director, Quality Assurance
* Minimum Requirements
* Bachelors of Science Desired: Bachelors of Science in Biology, Microbiology, Chemistry, Biochemistry, Pharmacy, Engineering, or related field.
* 10 + Years experience in QA, with a minimum of 3 years supporting GMP manufacturing, within the pharmaceutical industry
* Minimum of 5 years handling quality system investigations, CAPA, change control, etc.
* Works independently with minimum supervision to accomplish goals
* Good working knowledge and understanding of 21 CFR Parts 210, 211, and ICH Q7
* Relies on extensive experience and judgment to resolve simple to moderately complex issues
* Other Experience/Skills:
* Root-Cause Investigation and Statistical Analysis Experience.
* Regulatory compliance and/or previous regulatory audit experience.

Low Cost living.Company offers Custom organic synthesis, cGMP scale-up, Contract research, Molecular building blocks, Medicinal chemistry services and is a leader in fostering the commercial development of small molecule drug discovery and development in pharmaceutical, discovery platform, and biotechnology companies. The Co.offering parallels the drug discovery process and provides significant advantages at each step from lead discovery to lead optimization, chemical synthesis and scale-up of pharmaceutical intermediates as well as chemical process R&D.

REQUIREMENTS:

We are currently accepting resumes for the position of Sr. Quality Assurance Scientist.

Purpose
The Sr. QA Scientist is an advanced level position with hands-on QA experience in a pharmaceutical environment. Working independently and under minimum supervision, the individual will be working primarily to support to Manufacturing operations. The Sr. QA Scientist, will assure products are manufactured in compliance with internal, regulatory and industry standards, meets business needs and optimizes cost in the quality organization of the manufacturing facility.

Responsibilities

* Perform a wide variety of quality assurance activities to ensure compliance with internal procedures, applicable US regulatory requirements, and customer requirements for drug substances under clinical development
* Review and may approve documents such as standard operating procedures, manufacturing batch records, packaging and labeling records, test methods, specifications, stability protocols and reports
* Review executed production batch records and associated documentation including any deviation and investigation reports related to lot release
* Act as a compliance resource to provide guidance and assistance towards resolution of simple to moderate deviations, quality investigations, CAPAs and change control; review and may approve quality system documents related to manufactured products
* Perform product complaints investigations
* Ensure compliance with company policies and SOPs as well as FDA and other applicable guidelines.
* Assist with hosting and responding to client audits
* Assist with developing and maintaining companys quality system
* Support continuous improvement of quality systems; author new, revise existing and may review department procedures and/or forms
* Support quality systems, as needed (e.g., issue and track closure to change controls, deviations, quality investigations, CAPAs)
* Assist with inspection preparation and inspection strategy room for regulatory agency inspection or third party audits
* Serve as a backup to Senior Document Control Specialist, Associate Quality Assurance Scientist and Sr. Quality Assurance Scientist
* In the absence of the Director, Quality Assurance provide guidance to the QA department.
* Other duties as assigned and / or developed by Director, Quality Assurance
* Minimum Requirements
* Bachelors of Science Desired: Bachelors of Science in Biology, Microbiology, Chemistry, Biochemistry, Pharmacy, Engineering, or related field.
* 10 + Years experience in QA, with a minimum of 3 years supporting GMP manufacturing, within the pharmaceutical industry
* Minimum of 5 years handling quality system investigations, CAPA, change control, etc.
* Works independently with minimum supervision to accomplish goals
* Good working knowledge and understanding of 21 CFR Parts 210, 211, and ICH Q7
* Relies on extensive experience and judgment to resolve simple to moderately complex issues
* Other Experience/Skills:
* Root-Cause Investigation and Statistical Analysis Experience.
* Regulatory compliance and/or previous regulatory audit experience.
* No Sponsorship

Reference: 559199082

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