This 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 this 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 this company, its operations, or its staff.
Top 3 Must Have Skill Sets:
Day to Day Responsibilities:
- GMP experience (Preferably in biotech or similar industry)
- Laboratory/analytical background (Preferably in biotech or similar industry)
- Detailed-oriented/Problem solving/Troubleshooting
- Manual visual inspection operations
- Analytical testing
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.
"This posting is for Contingent Worker, not an FTE"
- 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.