Manager, QC Lab Remediation

About the role

The QC Laboratory Remediation Manager plays a crucial role in ensuring regulatory compliance and implementing continuous improvement initiatives within the quality control labs at Curia. This position involves leading remediation programs, preparing for regulatory inspections and audits, and driving improvements in lab systems and methodologies.

Responsibilities

• Establish and maintain QC lab remediation and continuous improvement programs
• Work with QC supervisors and QC Manager to meet regulatory inspection and customer audit commitments
• Trend QC lab performance metrics, identify areas for improvement, and implement robust CAPAs
• Lead QC lab inspection readiness plans and perform gap assessments
• Develop and implement a compliant and practical training and qualification program
• Support QC lab LIMS implementation, acting as a conduit between site QC operations, IT, and Global Quality Systems teams
• Identify and implement new and improved ways to perform tasks by challenging established procedures

Requirements

• Bachelor’s Degree in Chemistry or relevant field
• Minimum of 5 years of relevant work experience, with 2 years in a team leadership role
• Investigations experience including root cause analysis, writing, and CAPA identification
• Good understanding of GMP requirements for QC operations
• Previous experience managing a QC team in a commercial product GMP environment

Qualifications

• Advanced degree in Chemistry or related field
• Pertinent training/courses
• Experience in a cGMP QC environment
• Supervisory responsibilities

Skills

• Ability to recognize and take action on necessary tasks
• Strong oral and written communication skills
• Expertise in cGMP, USP, EP, and FDA regulations
• Technical competence in understanding and interpreting lab techniques
• Proficiency in computer software, including Microsoft Office Suite
• Organizational skills and ability to multitask
• Knowledge of FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485

Benefits

Curia offers a range of benefits including generous benefit options, paid training, vacation and holidays, career advancement opportunities, education reimbursement, a 401K program with matching contributions, and access to a learning platform. Additionally, employees can expect to participate in ongoing professional development and contribute to the advancement of life-saving treatments through their work.

Pay

The pay range for this position is $105,000 - $131,200, with considerations for education, experience, location, and tenure. Curia is committed to providing competitive compensation packages to attract and retain top talent.