Job Description

The CAPA Compliance Manager is responsible for maintaining all CAPAs and customer complaints in a compliant state at the Chicago Heights plant. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. This role is essential in maintaining an effective quality system at the Chicago Heights plant while meeting customer’s expectations.

ESSENTIAL DUTIES:

• Responsible for maintaining all CAPAs and customer complaints in a compliant state at the Chicago Heights plant.
• Extensive technical writing capability for deviations and customer complaint investigations
• Develops, documents, and tracks to completion corrective and preventive actions (CAPA) to prevent nonconformities from occurring again
• Investigates nonconforming events, develops CAPAs, root cause analysis, drafts documents, coordinates processes, and drives approval and resolution of all corrective and preventative actions
• Takes full responsibility of communication with customers and customer care to resolve issues with product and/or customer expectations.
• Holds regular review meetings and monitors tasks to ensure timely completion
• Evaluates all customer complaint samples and enter them into SAP
• Makes all customer complaints folders and updates SAP as required.
• Reports compliance status data to operational quality management.
• Works with internal staff to resolve quality issues.
• Assists Quality Management in preparing quality related reporting and presentation materials. 
• Investigates customer complaints using root cause analysis tools and methodology.
• Collaborate with center management in the development and implementation of continuous improvement plans
• Participates in plant management staff meetings and quality initiatives
• Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management
• Support and developing site GMP, GDP, and 5S programs including leading team meetings and related activities
• Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards
• Respond to customer requests efficiently and effectively via email or phone.
• Facilitates quality related problem solving and work out sessions to address issues not requiring the formal DMAIC approach. (Only if not formalized as CIP project / initiative)
• Conducts special data analysis projects as requested by management.
• Facilitates project completion by recognizing and addressing organizational barriers.
• Instructs and coaches managers, supervisors and team leaders to establish performance measurement systems and goals aligned with organizational objectives.
• Utilizes Infinity QS or establishes Statistical Process Control charts where applicable and trains process owners in their proper use.
• Works with process owners and IT resources to make data available to process owners and for process improvement teams.
• Observes all safety rules and regulations and performs job in a safe manner.
• Maintains acceptable standards of housekeeping & wears proper personal protective equipment (PPE)
• Lead and develop corrective & preventive actions in regard to internal and external customer complaints.
• SAP including processing requisitions and budget maintenance.
• Communicate plant mould equipment needs with vendors; follow up with planning to ensure timely deliveries. 
• Ability to identify complex problems related to production, develop and evaluate options, and implement solutions by developing procedures and training.
• Perform other duties as assigned by the Quality Manager.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.

QUALIFICATIONS & SKILLS:

• GMP and GDP compliance experience is required. Pharmaceutical packaging experience is a plus.
• Good communication skills; verbal and written
• Good interpersonal skills and organizational skills.
• Sound mathematical and technical skills.
• Ability to communicate with all levels within the organization.
• Analytical and synthesis skills.
• Organizational skills and ability to multitask (work on several projects at once).
• Project Management Skills
• Problem solving and analytical skills
• Ability to think logically and methodically.
• Ability to influence decision making independently and proactively.
• Excellent computer skills (Microsoft Office Suite, specifically Excel, Word, and Outlook).
• Strong customer service skills
• Strong critical reasoning, decision-making and problem solving skills to analyze situations
• Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives
• Understand Quality Systems and/or regulated training requirements
• Occasionally required to work with the public when they are dissatisfied

EDUCATION/EXPERIENCE:

• A four-year college degree, preferably in a technical field, is strongly desired. In lieu of a degree appropriate job experience can be considered.
• Previous experience dealing with customers inside and outside of the facility.
• 5 years of experience working in manufacturing quality, compliance, project management, or regulatory.
• Speak and write English fluently.

Preferred Certifications:

• Lean Six Sigma Black or Green Belt preferred
• CSSBB, CQE, CQA, CQM or other quality certification preferred
• Project Management Certificates (PMI, PMP) is preferred
• Exposure to loud noises, hot and cold temperatures, sudden temperature changes, and various odors

Additional Information

BEHAVIORAL ATTRIBUTES:

• A strong individual contributor that exhibits the company values-Integrity, Responsibility, Excellence, Innovation & Teamwork
• Able to maintain confidentiality
• Self-starter-able to work with minimal supervision
• Able to handle pressure of time constraints in meeting Quality goals
• Detail oriented, strong organizational skills
• Dependable, punctual and attentive
• Competent and conscientious