QA Coordinator Compliance

General Description:

Under the direction of the Quality Systems Manager, the Quality Assurance Compliance Coordinator will assist in administration of audit programs to meet customer, regulatory and quality requirement.

Specific Responsibilities & Duties:

A.    Internal Audits:

• Helps develops audit checklists
• Participates in routing facility walk-throughs
• Document audit observations, take meeting minutes
• Incorporates observation into audit tracking logs for internal and external audit findings
• Communicates audit findings to appropriately departments.
• Performs monthly audits of documents, training, and competency. Alerts management when documents are out of date.
• Collaborate closely with Quality Assurance to support compliance oversight and assist with updating SOPs and other documents as necessary

B.    Customer/Regulatory Audits

• Assists in the scheduling of audits.
• Participates in audits
• Completes audit work papers and documents audit observations and findings.
• Accomplishes compliance audit requirements by orienting, training, and guiding compliance colleagues. 
• Prepares for audit by researching materials, formulating a plan of action and terms of reference. 
• Communicates audit progress and findings by preparing reports, providing information in meetings. 
• Supports external auditors, if required, by coordinating information requirements and keeping track of the audit progress. 

C.    Systems Maintenance

• Promotes a safe working environment and adheres to Health, Safety and Environmental procedures, company safety rules, Current Good Manufacturing
• Practices (CGMP’s), and Standard Operating Procedures (SOP’s) at all times.
• Coordinate, track, and maintain revision history and records for active and obsolete forms and documents
• Assists developing and maintaining audit logs to track observations and related improvements.
• Helps develop action plans based on audit observations
• Helps coordinate meetings to discuss audit related projects
• Follows up with responsible parties to ensure required projects are completed within established timelines
• Provides Quality System Manager with updates on projects that are behind schedule
• Helps develop and monitor effectiveness checks upon completion of audit related CAPA

Physical Requirements

• Capable of lifting up to 25 lbs.
• Capable of standing, walking, and sitting for extended periods

Qualifications:

• High school education or equivalent.
• College degree in chemistry or life sciences, or combination of education and experience in cosmetics or related (FDA regulated) industry preferred.
• Experience with cosmetics, OTC or pharmaceutical products preferred. 
• Understanding of drug CGMPs preferred.
• Must be able to successfully communicate and interact with internal and external customers.
• Must be extremely detail oriented. 
• Must have a minimum of 2-3 years’ experience in Quality Systems & Audit role preferably in cosmetic process manufacturing or an FDA regulated industry.
• Working knowledge of QC, QA, analytical method development or method validation functions
• Understanding and knowledge of FDA guidelines
• Significant knowledge of CGMP regulations for commercial manufacturing.
• Must be able to maintain a clean, sanitary, and organized work area. Maintains housekeeping in conformance with, Current Good Manufacturing Practices (CGMP’s), and Standard Operating Procedures (SOP’s)
• Good time-management skills
• Good English communications skills: speaking, reading, and writing.
• Advanced PC Knowledge i.e. MS Office Suite (Excel, Word, Outlook) is preferred
• Flexibility to work long hours during peak season or special schedules as needed to satisfying job requirements.
• Ability to multi-task and follow through on project assignments
• Ability to quickly remedy procedural problems
• Good interpersonal and customer service skills
• Excellent organizational and planning skills 
• Makes suggestions for improvements
• Communicates and collaborates with management

Work Environment:  

• Process Manufacturing
• Laboratory/Office environment
• Noise level is low to moderate
• Proper lighting and ventilation