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18 days old

Document Control Analyst/Labeling Specialist

Kelly Services
Carlsbad, CA 92008
PLEASE NOTE: Must be authorized to work lawfully in the United States for any employer without sponsorship.


Kelly Science & Clinical is seeking a Document Control Analyst/Labeling Specialist to join their team in Carlsbad, CA for an American provisioner of scientific instrumentation, reagents and consumables, and software and services to healthcare, life science, and other laboratories in academia, government, and industry. For immediate consideration, please email your resume directly to Regan.Brown@KellyServices.com as well as apply online.


**Document Control Analyst/Labeling Specialist**


**12-Month Contract (full-time, W2)**

**Pay Rate: $25.00/hour**


When you join us at Company, youll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.


Location/Division Specific Information:

The role is responsible for Document Control Management of a recently built enzyme manufacturing facility serving pharmaceutical customers. This operation is part of our Biosciences Division (BID), part of our Life Sciences Solutions Group (LSG).


BID is experiencing an outstanding growth supporting exciting markets: Academia, Research, Biotech, Pharma, Cell and Gene Therapy and Medical Devices.


How will you make an impact?


+ We are looking for a self-driven, experienced and resourceful Document Control Specialist to support with the buildout of our document control system, ensuring compliance to all applicable standards.


What will you do?


+ Day-to-day support of the document control workflow, which is the vehicle to execute the request for changes within a ISO 9001 and Pharmaceutical GMP Quality Management System.

+ Support the coordination, preparation and implementation of controlled documents via Document Change Orders (DCOs) and Engineering Change Requests (ECRs).

+ Review and edit product documentation for consistency in content. Interact with appropriate departments/sites to resolves discrepancies.

+ Assist with global document review boards ensuring that document changes which impact multiple sites are appropriately updated congruently to prevent process drift.

+ Drive continuous improvement of Document Control process by employing Practical Process Improvement concepts, managing metrics, reporting and communicating internally to Leaders and diverse audiences.

+ Determine required approvers and route corresponding DCO/ECR in Agile. On completion of change, ensure manufacturing documentation is available at the point of use.

+ Provide notification to appropriate departments, where applicable.

+ Prepare physical binder of Quality Management System (QMS) documents for audit support.

+ Train staff to document control processes, Good Documentation Practices (GDP), etc.

+ Compile master data for entry into Agile document management system.

+ Transfer documents to new approved templates.

+ Perform other duties and cross training, as assigned.


How will you get here?


+ Education:

+ Associate degree from accredited college/university or equivalent experience. Bachelors degree in Science, Engineering, Biochemistry, Biotechnology, Biology, or Biomedical Engineering preferred.

+ Experience:

+ Requires a minimum of 2-3 years relevant experience in a regulated document control environment.

+ Strong working knowledge of computer applications and current software (Microsoft Excel, Outlook, Word, Project and PLM/ERP system).

+ Knowledge, Skills, Abilities:

+ Experience with Agile and MasterControl electronic document control systems preferred.

+ Works independently on new and on-going assignments.

+ Identifies and solves problems using established business rules and procedures.

+ Detail oriented and accurate.

+ Strong verbal and written communication skills.

+ Continuous improvement minded.

+ Knowledge of quality standards (e.g., 21 CFR Part 820, ISO 9001, ISO 13485, MDSAP, excipient manufacturing regulations) and 21 CFR part 210/211, ICH Q7 and EudraLex volume 4 experience preferred.


**Why Kelly:**


As a Kelly Services employee, you will have access to numerous perks, including:


+ Exposure to a variety of career opportunities as a result of our expansive network of client companies.

+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career.

+ Access to more than 3,000 online training courses through our Kelly Learning Center, including accredited courses to obtain IT certifications, as well as PDU-approved courses.

+ Weekly pay.

+ Group-rate insurance options available immediately upon hire.*


**Apply today!**


**Refer a friend!**


*Available for purchase and administered by a designated third-party vendor. (25/33.33)


**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)
Posted: 2021-09-29 Expires: 2021-10-30

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Document Control Analyst/Labeling Specialist

Kelly Services
Carlsbad, CA 92008

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