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4 days old

Quality Control Analyst II

Kelly Services
Lexington, MA 02421
Kelly is hiring a **Quality Control Analyst II** for one of our pharmaceutical clients in **Lexington, MA.**


+ 9-12 month contract with potential temp to perm possibility for the right candidate

+ Remote but must be local

+ $40-53/hr


**OBJECTIVES/PURPOSE**

Project Management of Stability Studies for Drug Products, Drug Substances and Intermediates as well as associated Data Evaluations and Documentation

Assignment and continuous Monitoring of product shelf life

Authoring of technical documents for regulatory submissions


**ACCOUNTABILITIES**

Management of stability studies for assigned products

Generation of stability protocols and stability reports (e.g. final reports, PQRs, annual reports)

Authoring and review of stability sections for regulatory submissions

Writing and review of responses for health authority requests and communication with regional authorities

Statistical analysis and evaluation of stability data (e.g. Shelf Life or Internal Alert Limit determination)

Subject matter expert for stability during audits and inspections

Stability OOS/OOT investigation ownership

Evaluation of transport temperature excursions

Performing change request assessments with regard to stability

Generation and review of SOPs and forms for processes associated with stability study management

Implementation of Global Standards and Processes for Stability Study Management

Implementation of Continuous Improvement Projects within the Department

Coordination and Management of stability activities at external contract organizations (CMO, CTL, CRO) including procurement activities

Other Responsibilities and Projects as assigned.


**DIMENSIONS AND ASPECTS**

Technical/Functional (Line) Expertise

Experienced in GMP regulations and compliance requirements

Knowledge and understanding of ICH and other regulatory requirements.

Knowledge and ability to author stability CMC sections and regulatory responses

Experience with various quality systems (e.g. investigations, CAPAs and change controls)

Fluent in English (written and oral)

Good GDP skills

Technical writing skills.

Conducts work in compliance with cGMPs, safety and regulatory requirements

Relevant experience with pharmaceutical pipeline products and CMC aspects of regulatory filings.


Innovation

Scientific knowledge in protein / plasma / antibody chemistry / small molecule products

Good analytical and problem solving abilities

Experienced in working with global teams


Development of stability study design Setting up stability studies according to guidelines, regulations and internal procedures. Changes that could directly affect a license or development/ submission strategy

Selection of batches for stability Coordination of involved departments, assuring timely sample pull and study start Changes that could directly affect a license or development/ submission strategy

Evaluation and reporting of stability data Statistical evaluation, trending and determination of possible shelf life and storage conditions Final decision on product shelf life and storage conditions

Authoring stability sections for submissions Authoring of stability sections and data review Final review and approval of stability section

Stability OOS/OOT investigation ownership Assuring timely investigation progress and initial escalation, if applicable, Defining and Leading of Investigation Teams Higher level escalations and reporting decisions

Subject matter expert for stability during audits Presentation of product stability program or stability investigations Stability systems related topics

Writing of responses for health authority requests Providing additional requested stability data and answering questions regarding the stability program Authoring responses that could directly affect a license or development/ submission strategy

Evaluation of transport temperature excursions

Potential impact assessment of temperature excursions with respect to existing stability data Final Release decision of impacted material

Performing change request assessments with regard to stability Proposal of stability strategy to cover regional MOH expectations Final decision of stability strategy implementation according to proposal

Performing Shelf Life Extension studies and evaluation Feasibility assessment, extension of existing studies and (risk based) analysis of stability data Implementation decision, change control ownership and operational implementation


**EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:**


Typically requires Bachelor/ Master Degree in Science or Engineering or several years of Experience in pharmaceutical Industry Science related degree is preferred

Team Player

Good Communication Skills

Seeks and considers feedback

Global Cultural Awareness

Ability to prioritize work and multitask.

ADDITIONAL INFORMATION

Limited to no travel expected. Travel between sites may be required.



**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-10-11 Expires: 2021-11-11

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Quality Control Analyst II

Kelly Services
Lexington, MA 02421

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