Top 3 Must Have Skill Sets:
1. GMP experience (Preferably in biotech or similar industry)
2. Laboratory/analytical background (Preferably in biotech or similar industry)
3. Detailed-oriented/Problem solving/Troubleshooting
Under minimal supervision, responsible for one or more of the following activities in Manufacturing:
Analytical testing, characterization, sample and data management
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
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.
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)
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.
"This posting is for Contingent Worker, not an FTE"