Quality Assurance Supervisor

Responsibilities:

• Manage and schedule quality activities performed by QA Associates (batch record stage review, production quality inspection/ sampling /testing, etc.
• Raw Material/Packaging Component/Bulk Drug Product Release.
• Manage and coordinate raw material sampling/ release and bulk products review/release performed by QA Associates.
• Manage and coordinate equipment swabbing and release performed by QA Associates.
• Oversee liquid retains sample management and APR review.
• Provide expertise to operations to resolve floor issues, implement corrections, and assure deviations are opened.
• Collaborate with various departments to meet quality requirements and fulfill business needs.
• Provides manager with quality indicator data derived from supporting systems such as CME.
• Coordinates interdepartmental activities with QC, Supply Chain and Operations to meet business needs.
• Responsible for quarantining/rejecting product due to investigations disposition, field alerts, recalls, etc.
• Responsible for overseeing movement of controlled substance within their designated facility to and from secured location.
• Back up reviewer and approver of master packaging records in support of operations.
• Back up QA reviewer of environmental monitoring alarms.
• Back up for executed packaging and manufacturing batch record review.
• Author and review SOPs relevant to the job duties.
• Initiate deviation reports and supports investigative process.
• Monitor manufacturing and packaging processes to assure cGMP compliance and adherence to company SOPs.
• Assist internal quality initiatives and internal audits as required; assist as needed with FDA inspections.
• Provides guidance, training, cross-training, coaching and work assignments for QA Associates.
• Selects, develops, evaluates personnel to ensure efficient operation of QA function.

Requirements:

• Bachelor’s degree in Chemistry, Life Science, or related field.
• 7+ years of related experience in in a cGMP/pharmaceutical environments or equivalent.
• 2+ years’ supervisory experience.
• Experienced in training techniques.

Knowledge:

• Understanding of cGMP principles, solid dosage manufacturing and packaging, DEA regulations
• Solid understanding and use of ANSI sampling techniques and principles.
• Intermediate computer skills.

Skills & Abilities:

• Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.
• Technical Skills - Assesses own strengths and weaknesses; pursues training and development opportunities; strives to continuously build knowledge and skills; shares expertise with others.
• Customer Service - Manages difficult or emotional customer situations; responds promptly to customer needs; solicits customer feedback to improve service; responds to requests for service and assistance; meets commitments.
• Interpersonal Skills - Focuses on solving conflict, not blaming; maintains confidentiality; listens to others without interrupting; keeps emotions under control; remains open to others' ideas and tries new things.
• Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates group presentation skills; participates in meetings.
• Written Communication - Writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.
• Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
• Able to effectively handle conflict/resolution situations between different departments and inter-department.
• Able to analyze and troubleshoot problems.