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20 days old

Quality Assurance Specialist

Kelly Services
Gaithersburg, MD 20898
Kelly Services is seeking a **Quality Assurance Specialist** for a biotechnology company in **Gaithersburg MD.**



Contract role from 9/1/2020-3/31/2021



**Job Description**



Supports a number of functional areas including documentation, on-the-floor manufacturing support, facilities, and other Quality departments.

Performs edit, review, and approval of documents submitted for edit/review/approval to ensure compliance with existing document control procedures.

Issue controlled documents, i.e. Batch Production Records, Logbooks, Electronic Forms.

Maintain document tracking system, issue and track document distribution.

Maintain document archive via EDMS System (electronic) and storage of hard copy documents.

Support archive users by performing database searches, file retrieval and photocopying as needed.

Provide customer support related to GXP documentation.

Generate reports from the electronic document management system as necessary.

Complete routine archive operations for GLP, GCP and GMP paper records generated at the Gaithersburg site(s) under the supervision of archive personnel in accordance with approved procedures as required.

Responsible for assuring the quality of clinical products manufactured at MedImmune and contractors.

On the floor real time review and investigations.

Reviews documents such as SOPs, deviations, change control requests, corrective and preventive action plans, validation protocols/reports, technical reports, etc., that are submitted to QA for approval.

Utilizes quality assurance system in compliance with current good manufacturing practice regulations.

Administers the change and Deviation and corrective action systems for assigned products and quality systems.

Manages work flows to assure timely supply of product.

Supports the evaluation and disposition of labeling, raw materials, intermediates and finished products through timely compliance evaluation of batch records, laboratory results and other cGMP documents.

Investigates and assesses the impact of minor and major deviations that may occur during manufacture, testing or distribution of products or during the administration of quality systems.

Identifies root causes and recommends and implements corrective actions to prevent recurrences.

Performs trend analysis to monitor process and facility performance.

Performs in-plant inspections of active production areas to resolve problems early and to ensure compliance with SOP and regulatory requirements.

Perform edit, review, and approval of GxP controlled documentation including Master Production Records (MPRs) and Solution Preparation Records (SPRs) in accordance with procedures to ensure compliance.

Contributes to the completion of routine tasks.

Frequent use and application of technical standards, principles, theories, concepts and techniques.

General supervision and instructions given for routine work and detailed instructions given for new activities or special assignments.

Develops solutions to routine technical problems of limited scope.





**Required**

B.S. in Biology, Chemistry, Engineering Business or equivalent experience.

Proficient in Outlook, Electronic Document Management Systems, Internet Explorer, Microsoft Office Applications including SharePoint.

3+ years of experience in a regulated environment





**Desirable**

1-2 years of experience in a production environment.

Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations. Ability to write reports, business correspondence and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

Ability to define problems, collect data, establish facts and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables




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



As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.




**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. 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.

\#KellyGTS
Posted: 2020-07-17 Expires: 2020-08-17

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Quality Assurance Specialist

Kelly Services
Gaithersburg, MD 20898

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