Job Details

  • Title: Sr Associate
  • Code: RCI-9309
  • Location: Thousand Oaks, CA 91320
  • Posted Date: 10/13/2021
  • Duration: 12 Months
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  Job Description

Description:

 

  • Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment at Company.
  • In accordance with applicable law, Company will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance.
  • Such accommodation may not pose an undue hardship to Company, its operations, or its staff.
  • ** Must sit onsite, M-F : 7:00am-4:00pm standard hours, however there may be some early or late days that are known ahead of time **

Job Summary:

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.

Specific Job Duties:

  • 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
  • Perform accurate laboratory/manufacturing documentation following GMP guidelines.
  • With a high degree of technical flexibility, work across diverse areas within the lab.
  • Evaluate analytical data
  • Perform general lab/area 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 be departmental or organizational in scope
  • Evaluate lab practices for compliance and operational excellence improvements on a continuous basis
  • May participate in lab/inspection deviation investigations
  • May own deviation/CAPA records
  • May provide technical guidance
  • May train other staff
  • 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 Education:

  • Bachelor’s degree in Life Sciences & minimum 2 years of biotech industry QC experience/GMP laboratory/manufacturing (preferably in manual visual inspection) experience.
  • Experience with regulatory compliance in GMP manufacturing and testing of pharmaceutical products.

Skills:

  • 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.

Top 3 Must Have Skill Sets:

  • GMP experience (Preferably in biotech or similar industry)
  • Laboratory/analytical background (Preferably in biotech or similar industry)
  • Detailed-oriented/Problem solving/Troubleshooting

Day to Day Responsibilities:

  • Manual visual inspection operations
  • Analytical testing