3 Key Consulting, Inc.

Quality Assurance Senior Associate - (JP10386)

3 Key Consulting, Inc.  •  Louisville, KY (Onsite)  •  19 days ago
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Job Description

Job Title:  Quality Assurance Senior Associate - (JP10386)
Location: Louisville, KY.  40201
Employment Type:  Contract
Business Unit: International and Distribution Quality
Duration: 2+ years (with likely extensions)
Notes:  Only qualified candidates, please.
Posting Date:  06/02/22

3 Key Consulting is hiring a Quality Assurance Senior Associate for a consulting engagement with our direct client, a leading global biopharmaceutical company.

  • Perform receipt, manufacturing, storage, distribution, and Facilities & Engineering documentation review to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations
  • Perform cGMP process, procedure, document and record review, approval and tracking, including but not limited to Deviations, CAPAs, Change Controls, and Validations. May also support execution of these tasks.
  • Perform routine Quality Assurance assessments of site operations and provide direct oversight.
  • Support Labeling and Packaging Operations including incoming raw material inspection and manufacturing oversight.
  • Represent the Quality Unit during audits and inspections as needed.
  • Support internal/external audits and inspections as part of the audit/inspection team as needed.
  • Perform additional duties as specified by management

Basic Qualifications:
  • Master’s degree and 1 year of Quality experience
  • Bachelor’s degree and 2 years of Quality experience OR
  • Associate’s degree and 6 years of Quality experience OR
  • High school diploma / GED and 8 years of Quality experience

Preferred Qualifications:
  • Ability to interpret and apply cGMP and GDP
  • Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry
  • Good written and oral communication

Why is the Position Open?
Supplement additional workload on team.

Top Must-Have Skill Sets:
  • Self starter
  • Attention to detail
  • Good written and oral communication
  • ** Regulated environment experience/ understanding of regulations **

Day to Day Responsibilities:
  • Perform receipt, manufacturing, storage, distribution, and Facilities & Engineering documentation review to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations
  • Perform cGMP process, procedure, document and record review, approval and tracking, including but not limited to Deviations, CAPAs, Change Controls, and Validations. May also support execution of these tasks.
  • Perform routine Quality Assurance assessments of site operations and provide direct oversight.
  • Support Labeling and Packaging Operations including incoming raw material inspection and manufacturing oversight.
  • Represent the Quality Unit during audits and inspections as needed.
  • Support internal/external audits and inspections as part of the audit/inspection team as needed.
  • Perform additional duties as specified by management

Red Flags:
  • Inconsistent work history
  • Candidate should have regulated environment experience/ understanding of regulations

Interview process:

Phone screening followed by in-person interview.


We invite qualified candidates to send your resume to  resumes@3keyconsulting.com  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

3 Key Consulting, Inc.

About 3 Key Consulting, Inc.

3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries. With 12 years of experience, 3Key has established a vast network of industry professionals and forged strong partnerships/alliances with key academic institutions across the country to continually develop our business professional and niche skill pipeline.

3KC offers a full suite of staffing solutions including PEO and compliance services. 3KC has several technology and industry domain practices including competencies in business intelligence, healthcare and life sciences.

People, process, and technology are 3 key areas of focus that we carefully examine individually and jointly, in order to deliver on our client's 3 key areas of focus - better, faster and cost effective BI and staffing solutions.

MISSION:

To create a better work experience for our customers, partners and employees through exceptional dedication and performance.

• We make hiring easier

• We build strong teams

• We bring about positive outcomes

VISION:

3 Key Consulting’s responsibility is to continually improve the manner and efficiency in which human resources and businesses are brought together to create value. Our vision is to put programs into action that improve market efficiencies while helping businesses and people be more productive.

Industry
Unknown
Company Size
1-10 employees
Headquarters
Simi Valley, CA
Year Founded
2009
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