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QC Associate III

CMC Biologics 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.
Primary Duties:
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
Education:
BS in chemistry, biology or other relevant discipline or equivalent work experience
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.
CMC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. EOE
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