QC Associate III 2149
Our client is a contract development and manufacturing organization (CMO). The company manufactures protein-based biological drug substance candidates for human clinical trials and commercial production under contract for biotech and pharmaceutical companies. We are currently seeking high-performing individuals to join this exciting and high-growth business.
- Performs complex and routine laboratory activities in support of environmental and utility monitoring testing, GMP testing, and Raw Materials testing.
- Coordinate laboratory maintenance activities, including the monitoring of supply inventories and equipment calibration status.
- Independently completes route and new QC tasks with minimal to no supervision
- Assists in validation/qualification/development studies
- May introduce new QC methodologies
- Demonstrate a high level of compliance with company documentation practices
- Work as a member of a fully-integrated team.
- Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
- Other duties as assigned
Experience and Critical Skill Requirements:
- 4-8 years of relevant QC experience, an MS may partially substitute for work experience
- Strong understanding of basic scientific concepts in multiple QC technical areas (e.g. bioburden, endotoxin, HPLC, TOC, conductivity)
- Experience with relevant analytical lab equipment and computers
- Proficient with Microsoft Office Suite – Word, Excel, PowerPoint, Sharepoint, etc.
- Experience participating in laboratory investigations of OOS/OOT results.
- Experience in preparing for or participating in laboratory compliance audits and/or inspections by regulatory agencies.
- Excellent written communication skills and proven ability to translate technical data into concise narrative/summary.
- Ability and desire for problem solving and decision making in a cross-functional team setting.
- High attention to detail, excellent organizational skills, and ability to work on multiple projects with tight deadlines.
- Excellent interpersonal and verbal communications skills, and ability to deal effectively with a variety of personnel both inside and outside the company.
- Flexible, high level of integrity, action- and goal-oriented.
- Enjoy a fast-paced, team-oriented, and collaborative environment.
- BS in chemistry, biology or other relevant discipline or equivalent work experience