Associate Manufacturing Process Technician (JP5147)

Location: Thousand Oaks, CA
Date Posted: 12-20-2018
Job Title:  Associate Manufacturing Process Technician (JP5147)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit:  Clinical Fill
Duration: 1+ years (likely extensions and possibility of conversion to permanent)
 
3Key Consulting Inc. is recruiting for an Associate Manufacturing Process Technician with a bachelor’s degree and 2+ years’ experience in biopharma quality control and GMP laboratory experience for a global, CA-based, bio-pharmaceutical company.
 
Job Description:
Under minimal supervision, responsible for one or more of the following activities in Manufacturing:
  • Analytical testing, characterization, sample and data management;
  • Equipment maintenance;
  • Contributes to team by ensuring the quality of the tasks/services provided by self;
  • Contributes to the completion of milestones associated with specific projects or activities within the team;
  • Support manual visual inspection of filled units.
This role will support manufacturing operations, as such some extended hours, shift, and weekend work flexibility may be necessary as required.
 
Top Must-Have Skill Sets:
  • Pharma GMP experience (preferably in manual visual inspection)
  • Project management
  • Shift flexibility
 
Day to Day Responsibilities
  • Manual visual inspection assay testing.
  • Plan and perform routine analyses with efficiency and accuracy.
  • Plan and perform multiple, complex routine/non-routine methods and procedures and a large variety of assays.
  • May perform aseptic aliquoting, sampling and analysis of compendia methods
  • Prepare complete and accurate laboratory documentation following GMP guidelines.
  • With a high degree of technical flexibility, work across diverse areas within the lab.
  • Evaluate analytical data
  • Perform general lab housekeeping
  • Maintain/operate specialized equipment
  • Comply with safety guidelines, GMPs and other applicable regulatory requirements
  • Initiate and/or implement changes in controlled documents
  • Troubleshoot, solve problems and communicate with stakeholders
  • Participate in audits, initiatives, and projects that may de departmental or organizational in scope
  • Evaluate lab practices for compliance and operational excellence improvements on a continuous basis
  • May participate in lab/inspection investigations
  • May provide technical guidance
  • May train others
  • May contribute to regulatory filings
  • May represent the department/organization on various teams
  • May interact with outside resources
  • Support manual visual inspection of drug product filled units
  • Deepens technical knowledge trough exposure and continuous learning
 
Basic Qualifications/Skills:
  • Bachelor’s degree in Life Sciences & minimum 2 years of biopharma industry QC experience or related quality control or GMP laboratory experience.
  • Experience with regulatory compliance in GMP manufacturing and testing of pharmaceutical products.
  • Take initiative to identify and drive improvements.
  • Excellent verbal and written communication skills.
  • Strong technical writing skills for GMP documentation (e.g. investigations, procedures, change controls).
  • Presentation skills.
  • Escalate issues professionally and on a timely basis.
  • Decision making skills.
  • Teamwork and coaching others.
  • Negotiation and influencing skills.
  • Project management and organizational skills.
  • Ability to interact with regulatory agencies.
  • Data trending and evaluation.
  • May set project timeframes and priorities based on project objectives and ongoing assignments. Recognizes and escalates problems.
  • Ability to work independently and deliver right the first-time results.
  • Follows procedures. Refers to technical standards, principles, theories and precedents as needed.
 
 
Why This Position Is Open:
Does not currently have skill set available within the organization. This is a backfill role for an employee transferring to another position at Amgen.
 
Employee Value Proposition:
This person will have the opportunity to gain extensive experience at a top bio-tech company. Could potentially turn into a full-time role in the future.
 
Red Flags:
  • No GMP experience.
  • No manual visual inspection.
 
Interview process:
Phone 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. You are also welcome to share this posting with anyone you think might be interested in applying for this role.
 
 
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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