QA Associate III 2148
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.
- 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
- 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.\