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QA 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:
Help maintain the quality systems, such as: deviation management, corrective action and preventative action (CAPA) management, lot disposition, materials management, document control, change management and training to ensure control of the manufacturing process.
Assess discrepancies from procedures and reviewing GMP raw data for compliance.
Reviews and signs executed process and solution MBRs.
Provides QA on the floor support
Prepares for and participates in compliance audits
Ensures acceptable quality and quantity of work executed.
Ensures that standard operating procedures are followed and are correct for bioprocess operations and equipment.
Ensures compliance with company quality systems, safety procedures, and other company policies.
Judgment required to apply industry practices and company policies to daily operations.
Other duties associated with a startup operation as assigned
Education:
BS in biology or other relevant discipline or equivalent work experience
Experience and Critical Skill Requirements:
4-8 years of relevant QA experience
Strong understanding of cGMP's and concepts in several quality systems
Understanding of basic scientific/technical concepts
Proficient with Microsoft Office Suite ? Word, Excel, PowerPoint, Sharepoint, etc.
Experience in preparing for or participating in compliance audits and/or inspections by regulatory agencies.
Excellent written communication skills
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
Flexible, high level of integrity, action- and goal-oriented.
Enjoy a fast-paced, team-oriented, and collaborative environment.
Proven ability to establish collaborative working relationships; team-oriented, but able to work independently.\
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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