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QC Associate

Alpha Consulting Irvine Contractor
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QC ASSOCIATE
IRVINE, CA
 
 
Project Description:
The QC Associate is responsible for performing hands-on quality related tasks in order to fulfill QA/QC support for implementing and maintaining QMS compliance as directed by management. This position is responsible for supporting and maintaining quality systems and functions within the company. This position may interact with management, partners, vendors, contract manufacturers and suppliers.  

The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Client policies and procedures. 
 
  • Assisting in variety of activities to ensure compliance with applicable quality and regulatory requirements. 
  • Participate in developing, reviewing and maintaining documents to include corporate level Standard Operating Procedures to ensure quality objectives are met. 
  • Inspect finished goods for compliance with established quality specifications. Work with contract manufacturer, receiving, operations and materials personnel to accurately complete required QC inspection and documentation, determine correct disposition, and apply correct status labeling in SAP. 
  • Detect nonconforming conditions during inspection and accurately document each condition. Assess product conformity to specifications and the authority to disposition in-process materials. Provide recommendation and address nonconforming conditions and processes.  
  • Identifying deviations and if occur have the authority and responsibility to refuse the release of a product if not comply with SOP. 
  • Review, release, check, retain sampling, general inspection of all incoming material inspection and resolving production problems. 
  • Develop and implement process improvements within own area and work effectively with teams to identify and develop process improvements. Participate in other continuous improvement activities. 
  • Maintain current knowledge of the basic requirements for compliance in own area of work and comply with those requirements. 
  • Interacting daily contact with Operations, Packaging, Marketing, R&D and Regulatory Affair departments. 
  • Reviews SOPs, general documentation and provide training as needed to other employees. 
  • Support stability program proactively working closely with outside vendors. 
 
 
Required Skills:
  • The successful candidate will have a minimum of a Bachelor of Science/Arts degree in scientific field, 3-6 years of experience working in the Pharmaceutical/Personal Care Industry.
  • Must possess knowledge of FDA 21 CFR Parts 210/211 and current.
  • Good Manufacturing Practices (cGMP). However, a combination of experience and/or education will be taken into consideration.
  • Experience in a quality assurance role in a GMP regulated environment is required: 
    • Working knowledge of Microsoft Office and TrackWise.
    • Ability to read and interpret complex business and/or technical documents. 
    • Ability to write comprehensive reports and detailed business correspondence. 
    • Must possess ability to work with managers or directors and communicate ambiguous concepts to groups across the organization. 
 
Physical Demands:
  • Routine standing, walking, sitting, keyboarding. 
 
 
This 6+ month position starts ASAP.
 
Please E-MAIL your resume (attachment to email) with rate and availability to Larry:  URL blocked - click to apply
 
 
ALPHA'S REQUIREMENT #19-01191
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

#ZR
 

Skills required

Certified Global Meeting Planner
Good Manufacturing Practices
Laboratory Information Management Systems
Raw Materials
Product Quality Control
Pharmaceutical Manufacturing
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Job ID: 19-01191

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Alpha Consulting
Corporation is a privately owned staffing firm operating from a single location
in East Brunswick, NJ. Alpha has staffed IT positions for major companies in
the pharmaceutical industry since 1994, with a special focus on project
management, product management, and program management.

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