Quality Control Manager

Quality Control Manager

Position Title: Quality Control Manager

EEO Category: 1^st/Mid Manager (11-1021)

Reporting into Title: Vice President of Liquids

Business and Department: ABF/L – Quality

Visual Pak Companies is an Equal Opportunity Employer. Visual Pak does not discriminate on the basis of race, color, religion, marital status, age, national origin, disability, medical condition, pregnancy, gender (orientation or identification), sexual orientation, veteran status, or any other basis covered by federal, state, or local laws. All employment decisions are based on qualifications, merit, skills, individual performance, and business needs.

Position Purpose/Summary: The Quality Control Manager is responsible for company and department quality manuals, policies and procedures to meet ISO certified Quality Management System (QMS) program requirements. This position will maintain and develop inspection procedures and quality standards to ensure business and customer specifications are met. The Quality Control Manager will improve customer, production and supplier quality by working with the business and customer on internal and external quality standards.   

Direct Reports

• Chemists
• Microbiologist  

Position Responsibilities-Tasks-Deliverables

All duties as assigned and the following specific activities.

• Lead and manage the quality department, including the Analytical Lab and Micro Lab, across three-shifts.
• Oversee the collection and production of samples in the laboratory to evaluate their quality.
• Monitor performance of quality control systems to ensure effectiveness and efficiency.
• Conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods or stability samples.  
• Monitors laboratory procedures and policies to ensure compliance to customer’s specifications.
• Produce reports regarding nonconformance of products or processes, daily production quality, root cause analyses, or quality trends.
• Manage and maintain all cGMP documentation
• Interface with Customer QC Departments; serve as technical resource for all Quality Control issues.
• Verify all inspection processes and procedures are conforming to established quality standards and required customer specifications.
• Oversee preparation and implementation of all departmental SOP’s.
• Complete and/or verify accurate completion of all QC documentation (forms, reports, etc.)
• Responsible for all QC Regulatory matters to ensure compliance with FDA, EPA, AIB, and OSHA.
• Investigate and correct customer issues and complaints relating to quality.
• Audit, write, revise, and verify quality standards and develop forms and instructions for recording, evaluating, and reporting quality data.
• Perform and/or arrange QC audits of the facility. 
• Oversee investigations and corrective actions relating to product quality problems and recommend changes for improvement.
• Produce reports regarding nonconformance of products or processes, daily production quality, root cause analyses, or quality trends.
• Implement quality control training programs
• Ensure appropriate training of all departmental personnel and coordinate inter-department communications.
• On call 24 hours to support quality department personnel across all shifts.

Key Performance Indicators (KPIs)

• First Pass Yields
• Data Integrity
• cGMP

Qualifications

Knowledge-Skills-Abilities 

Education:

• Bachelor’s degree in Chemistry or Biology is required.
• Six Sigma, Lean Manufacturing, Total Quality Management and Total Quality Control certifications preferred.
• Coursework in Quality, Management/Supervision/People Skills (Interpersonal Relationships)

Experience:

• Minimum of five years of liquid fill manufacturing operations management experience with multiple shifts, in high volume output facility.
• Minimum of 3 years’ experience in a leadership position of or within a quality management/continuous improvement environment.
• Experience in a commercial lab environment.
• Working knowledge of ISO reqs, CAPA, FMEA, and safety guidelines
• Strong knowledge of Validation protocols, IQ-OQ-PQ

• Leadership knowledge and skills to instill trust, provide direction, and delegate responsibly.
• Self-motivated and self-directed initiative to take action, achieves results, think creatively, and work efficiently and competently.
• Passionate about people development so as to cultivate staff talents and strengths, motivate successfully to reach potential, display commitment to their workforce, and seek continuous improvement of their own management skills and participation as a team member.
• Ability to address conflict and resolve well.

• Current GMP competency and best practice proficiency expected, with a relevant quality background required

• Knowledge and application of Processing Quality System policies and procedures
• Strong analytical skills.

Technology/Software :

• Proficient with Microsoft Office (Word, Excel, PowerPoint, Access).
• Must be proficient with Enterprise Resource Planning (ERP) and Warehouse Management Systems (WMS): use, implementation, selection, and training. 

Communication:       

• Communication skills including but not limited to: listening to others, processing information and expressing self effectively both verbally and in writing.
• Proven presentation skills, whether information based (reports and visuals) or verbally explaining the best and purposefulness of the business capability
• Strengths having to do with relationships so as to utilize abilities to build personal rapport and facilitate team success. Able to engage others, particularly clients, to support business relationships and foster new ones.
• Client interface so as to create trust and confidence in the organization’s offerings and reliability to meet their needs.

Physical Capabilities

Strength (lifting, dexterity, repetitive motion):

• Ability to lift up to 20 pounds.

Movement (standing, stopping, sitting, crouching, crawling):

• Regularly stands; walks; sits; uses hands to type, grasp/handle, or reach with hands and arms. May need to stoop, kneel or crouch.

Hearing (loud noise tolerance, quiet work area, public speaking, receive work direction):

• Reasonable capacity so as to accept and provide work direction or training in a loud, busy environment.

Vision (judge distance, read signs, extended computer work, identify details): 

• Utilizes close vision, distance vision, peripheral vision and depth perception.

MISCELLANEOUS

Travel: Percentage fluctuates, local travel only.

Vehicle (own): Preferred

Tools (own): N/A

Technology (own): N/A