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Form of workAGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visitwww.agcbio.com.
JOB SUMMARY
Performs basic QC analysis and documents activities according to SOPs following good manufacturing processes (GMP) and demonstrates ability to learn QC methods, procedures and systems.
ESENTIAL JOB DUTIES
- Assists with the creation of stability documents.
- Maintains the stability calendar.
- Assists with the scheduling of stability testing.
- Coordinates stability sample pulls and delivery for testing.
- Coordinates data compilation and CoA preparation.
- Perform general QC testing such as appearance, pH, Osmolality.
- Assist in drafting technical documents including test methods, validation documents, deviations, and stability reports.
- Assist with the generation of SOPs related to test methods and stability.
- Perform data verification and data entry.
- Receives/Ships stability and other samples for QC testing
ESSENTIAL RESPONSIBILITIES
- Supports projects/initiatives/team goals by delivering on all assigned tasks.
- Analyzes issues and makes decisions based on standardized processes and procedures under direct supervision.
- Seeks opportunities for continual learning.
- Receives close and regular instruction, guidance and direction from others in the form of steps and tasks.
- Develops skills in communicating concepts and interacting with others.
COMPENSATION RANGE:
$25/hr - $39.50/hr
Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.
Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.
Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company's performance and the Team Member's performance.
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
