Associate Manufacturing Process Technician (JP5147)
Thousand Oaks, CA.
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.
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:
Day to Day Responsibilities
- Pharma GMP experience (preferably in manual visual inspection)
- Project management
- Shift flexibility
- 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
Why This Position Is Open:
- 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.
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.
- No GMP experience.
- No manual visual inspection.
Phone followed by in-person interview.
We invite qualified candidates to send your resume to firstname.lastname@example.org
. 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.