Title:  Supervisor Quality Control (3rd shift)

Job Summary

Manage, coordinate and administer the site quality systems compliance: Document Control, CAPAs, Change Control, OOS, Deviation Reports.  Manage and support internal projects and ensure compliance with cGMP, applicable ISO requirements and company policies and procedures.

Essential Duties and Responsibilities

• Manage and support Document Control activities
• Manage the CAPA process including the review and approval to open new CAPA as well as approving CAPA plans, timelines and verification of effectiveness plans to assure timely completion within the established goals.
• Ensure deviation and nonconformance reports and OOS are completed properly, including root cause investigation (if required), effective correction(s) and corrective action(s) and closed within the established goal.
• Support Technology Transfer process as required.
• Support validation of facilities and equipment and process.  Approve engineering studies and other protocols as required
• Analyze data and provide reports and recommendations to management for continuous improvements
• Ensure proper completion of Change Controls and monitor timely completion.  Approve Change Controls for QA as needed.
• Manage and oversee site quality specialists.
• Review/approve customer specifications and ensure requirements are translated into site procedures and documentation.
• Provide for quality planning by preparing control plans and inspection documentation
• Define strategic plan to meet company and site goals
• Submit periodic reports on the status of compliance to quality system requirements
• Monitor and provide guidance to pest control service provider.  Communicate pest control issues and ensure resolution.
• Provide expertise and guidance for deployment of statistical methods in production.
• Performs other duties as assigned based on business needs.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance.
• Other duties as assigned

Education

• Bachelor’s degree Quality, Engineering preferred

Work Experience

• at least 3 years of experience
• One (1) year managing others directly

Preferred Knowledge, Skills and Abilities

• Demonstrated high degree of proficiency in MS Word, Excel and other Microsoft Office Programs required.  Demonstrated excellent communication skills both oral and written.  Demonstrated ability to investigate problems and issues in order to determine the root cause of failures
• Training in Six Sigma methodology
• Working familiarity with Project Management tools and Quality Risk Management
• Working knowledge of Pharmaceutical Industry requirements
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times.

Travel Requirements

Physical Requirements

Additional Requirements

• Must maintain the ability to work well with others in a variety of situations.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Must also be able to maintain confidentiality and resolve conflicts.
• Ability to make independent and sound judgments.
• Use written and oral communication skills
• Read and interpret data, information and documents
• Analyze and solve problems
• Use simple arithmetic reasoning
• Observe and interpret situations
• Learn and apply new information or new skills
• Work under deadlines with constant interruptions

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Shift

• Position is 3rd shift Monday -  Friday 10pm - 6am