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Senior Associate Laboratory Support (JP7742)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Senior Associate Laboratory Support (JP7742)
Location: Thousand Oaks, CA. (Onsite Essential)
Employment Type:  Contract
Business Unit: Drug Product, Supply, and Manufacturing
Shift: 7a-4p, must be flexible due to production demand, some weekends required
Duration: 1+ years (with likely extensions)
Posting Date: 10/1/20
3 Key Consulting is hiring an Senior Associate Scientist  for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:
  • Must have 2+ years of Pharma or Biotech manufacturing/laboratory or manufacturing support.
  • Analytical testing experience.
This is a manufacturing support role responsible for manual visual inspection and testing in manufacturing operations teams. This Senior Associate position will be focused on:
  • Characterization, sample, data, and equipment management.
  • Process improvement projects/assignments within operations.
  • Quality systems (Deviations/CAPA/CAPA EV/LIMS/MES/SAP/MAXIMO) support.
  • Support new product introduction activities.
  • Support production.
  • Maintain open communication between operations teams.
  • This Senior Associate position will be focused on manual visual inspection and testing in manufacturing operations.
Job Scope and Responsibilities:
  • Under minimal supervision, performs manufacturing and laboratory unit operations according to Standard Operating Procedures.
  • May schedule operations for multiple functional areas.
  • Understand process parameters and can identify process anomalies.
  • Perform data analysis of critical process parameters.
  • Operate complex critical processing equipmen.t
  • Assist, plan and implement continuous improvement solutions related to routine functions.
  • Assist in ensuring operations are completed per manufacturing schedule which may include delegation of tasks.
  • Primary resource related to processing operations on the mfg floor/laboratory.
  • Identify and propose solutions to complex problems.
  • Responsible for resolving problems during operations.
  • Perform initial review of manufacturing/laboratory procedures/batch records.
  • Review, revise, and audit documents.
  • Ability to perform computer operations (MES, EBR, MAXIMO, LIMS and SAP Knowledge).
  • May own deviations/CAPA or provide suggestions/ideas for corrective actions and preventative actions for deviations/safety incidents.
  • Applies research, information gathering, analytical and interpretation skills to problems of diverse scope.
  • Utilizes basic project management skills to set project timelines and priorities based project objectives and ongoing assignments.
  • Recognizes and escalates problems.
  • Able to establish working relationships with others outside area of expertise.
  • Ability and willingness to support flexible shift structure in support of operations (may include 24/7 or weekend).
  • Ability to understand, apply, and evaluate basic chemistry, biology, and physical principals as appropriate for the position.
  • Organizational skills and an ability to perform assignments with a high degree of attention to detail.
  • Written and oral communication skills. Technical writing capability.
  • GMP knowledge with ability to interpret and apply applicable regulations.
  • Ability to understand analytical methods for manufacturing/laboratory area.
Why is the Position Open?
Additional workload.
Top Must-Have Skill Sets:
  • Manufacturing GMP experience in biotech field.
  • Analytical testing experience, preferably in QC.
  • Flexible schedule based off production demand.
Day to Day Responsibilities:
  • Manual visual inspection of filled units.
  • Analytical testing for product release.
Basic Qualifications:
  • Bachelor’s degree and 2 years of experience in a biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality)
  • Associate’s degree and 5 years of experience in a biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality)
  • High School Diploma/GED and 8 years of experience in a biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality)
  • Prior experience with lab equipment, computers, and intermediate mathematical skills
Preferred Qualifications:
  • Experience with manual visual inspection and/or laboratory in a GMP regulated environment.
  • Experience with PAS X Werum software for electronic batch records with some understanding of editing and validation
  • Degree in Engineering, Chemistry, Biochemistry, Biology or Computer Science with experience in biotechnology
  • Demonstrated technical writing skills
  • Strong knowledge of manual visual inspection and laboratory background or strong understanding of related disciplinary areas in bioprocessing (Drug Product operations)
  • Demonstrated ability to work in a team
Employee Value Proposition:
Experience within a manufacturing setting & exposure to leadership/ departments.
Red Flags:
  • No GMP experience.
  • No analytical laboratory experience.
  • Unable to support dynamic production schedule.
Interview process:
Video Skype Panel 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.
3KC Talent Acquisition Team

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