OC Compliance Manager

Primary Responsibilities:

• Good understanding and knowledge of instrumentation, lab functions, and techniques to identify problems and must be able trouble shoot problems to the completion of work assignments.
• Become familiar with, and adhere to, requirements as documented in SOPs for Good Manufacturing Practices.
• Provides support to employees who lead or facilitate quality improvement activities.
• Provides project management, data analysis and measurement of outcomes, documents and reports the results and accomplishments for compliance initiatives; ensure laboratory is in full compliance to current regulations.
• Assures that improvement activities are documented and reported within the organization and externally as appropriate.
• Monitor and assess current projects for compliance risks.
• Evaluate all Laboratory activities relating to compliance.
• Audit processes and procedures
• Develop GAP plans for crisis events or compliance needs/violations
• Participate in new hire and employee onboarding and training on legal and compliance subjects
• Present audits, data, and procedures to other teams; advise on compliance issues across the company
• Assist the QC group with writing and editing of CCF, deviations, CAPA, OOS, and OOT
• Develop teamwork and communication skills through active listening and honest dialog with peers and supervisors. Manage multiple function per laboratory requirements.
• Communicate effectively with internal team personnel, as well as external team.
• Facilitate communication between External and Internal customers (Ambio, Inc.) as required
• Facilitate communication between QA and QC group to expedite QC activities for release, validation, etc.
• Evaluate team members performance and career development for next level.
• Other duties as assigned by management.

Qualifications:

• Minimum Education: Bachelor or Master’s degree in chemistry, life sciences, or related discipline.
• Minimum Laboratory Experience: 4+ years for Bachelor degree and 2+ years for Master degree of bench experience in an Quality Control laboratory environment.
• Must be proficient in HPLC/uPLC and use of Empower 3
• Must be experienced in data integrity requirements and regulations
• Must be able to push, pull, squat, stand and walk through-out the day
• Must be able to lift up to 40lbs.
• Must be able to wear a respirator off and on throughout the day.
• Proficiency in use of software including Microsoft Word and Microsoft Excel.
• Good communication and writing skills.
• Empower software proficiency is required.
• Must be able to wear safety shoes & glasses through-out the day while in designated areas. (provided by the company)
• You must be cleared by a physician to wear a respirator throughout the day while in designated areas. This is a condition of employment required for the above position.
• You must be able to work in a chemical environment.

Available Sites & Buildings

If you’re thinking about bringing your business to South Carolina’s Aiken, Edgefield, and Saluda region, we’re ready to accommodate you with a broad variety of existing facilities and ready-to-build sites.

Education

The highly skilled workforce in the Aiken, Saluda, McCormick, and Edgefield region is ready to meet the challenges of a rapidly changing economy because of the emphasis on education.