Downstream Manufacturing Associate I/III
AGC Biologics
- Bothell, WA
- Permanent
- Full-time
- Responsible for adherence to all Standard Operating Procedures (SOPs), Master Production Records (MPRs), protocols, policies, regulatory requirements, good manufacturing practices (GMPs), and safety guidelines.
- Participates in and/or leads unit operations described in standard operating procedures, manufacturing batch records, and cGMP guidelines.
- Proactively works with all team members, subject matter experts, and management to achieve training competency in production operations.
- Setup, maintenances, and use of cGMP equipment as directed by standard operating procedures and manufacturing batch records.
- Ensure compliance with company quality systems, safety procedures, and other company policies.
- Participate and support a culture of continuous improvement. Effectively collaborates with cross functional partners such as Quality Assurance, Quality Control, Supply Chain, and Facilities
- Reviews executed batch production records to ensure compliance with approved procedures and GMP expectations.
- Operate analytical equipment, including analytical scale, pH meter, spectrophotometer, filter integrity tester, etc…
- Mix, store and dispose of chemical solutions (may include hazardous material).
- Works in a cleanroom environment, performing aseptic processing while maintaining manufacturing environmental conditions.
- Solid interpersonal and teamwork skills, able to work cross-functionally and collaborate with various levels.
- Ability to work in a cleanroom environment for extended periods of time.
- Flexible, have the availability to work hours necessary to support production and / or maintenance activities.
- Ability to lift up to 50 lbs. with assistance, push, pull, bend, and stand for prolonged periods of time.
- Willingness to learn and advance within the company and/or department.
- High school diploma or equivalent required.
- Bachelor’s degree or Biotech certificate, quality systems regulations (cGMP) knowledge and clean room experience preferred but not required.
- Minimum 1 year of experience working within a federally regulated industry to be considered for a level greater than an Associate I
- For consideration for a Senior level associate must be proficient with the following systems
- Viral Segregation (Viral Inactivation/Viral Filtration)
- AKTA Operations
- Ultrafiltration and Diafiltration operations.
- Bulk Filling Operations.
- A pre-employment lift test and physical may be required for some positions within Manufacturing.