Quality Assurance Supervisor

RESPONSIBILITIES

:

• Manage change control of facilities, equipment and processes via paper and/or automated tracking system as required by cGMP. Maintain change/revision history.
• Work with Quality Systems, policies and procedures and all levels of facility personnel to achieve company quality standards and to ensure regulatory compliance.
• Administer and maintain Quality System documents – master records, SOPs, WI including filing, scanning and archiving activities, etc. Manage periodic document review activities assisting quality associates and other Functional Owners to update content and confirm training requirements. 
• Help guide Operations team in determining root cause of non-conformances/discrepancies and help develop corrective actions and verification activities.
• Author and/or revise Standard Operating Procedures, Work Instructions, and training modules with Functional Owners alignment to control critical systems and ensure conformance to FDA, States, and DEA regulations, and client-specific requirements.
• Lead, Manage, and Participate in internal and external audit program, as well as developing and training new auditors.
• Participate in validation program for annual review, new and requalification in all LSL facilities.
• Strong leadership skills and logistics (3PL) knowledge.
• Converse diligently with regulatory, State, Federal, and DEA agencies.
• Familiar in lean six sigma methodology.
• Support and assist all departments with research/investigation expertise to maintain compliance with business and regulatory needs.
• Support department teams to determine root cause of discrepancies and assist with developing corrective actions and verification activities as needed.
• Collaborate with Clients to ensure seamless execution of Quality Systems for product and processes throughout development and product distribution phases. Lead change initiatives by identifying best approach for implementing strategic processes.
• Work with Leadership Teams for policy writing and implementation and all levels of personnel to achieve company quality standards to ensure regulatory compliance.
• Support Quality Management Review process at least once per year.
• Direct, mentor and train direct report to support their career goals and LSL pipeline.
• This position does not have authority to sign contracts, LSL financial obligations, other than monthly expense reporting unless delegated by VP of Quality and Compliance.
• Other duties as assigned.

QUALIFICATIONS AND JOB SPECIFICATIONS

:

• Bachelor of Science (B.S.) degree in Engineering, Science or related field (preferred).
• Minimum of 2-5 years of experience in Quality in the medical device or pharmaceutical or other regulated industry.
• A minimum of two (2) years supervisory experience – Required.
• ASQ and/or ISO Auditor Certifications preferred.
• Demonstration of the following:
• Effective time management skills
• Impeccable verbal and written communication skills
• Ability to conduct appropriate research as needed
• Strong presentation skills
• Strong analytical skills for safety and compliance
• Attention to detail and organize
• Critical thinking
• Interest in working in a fast-paced environment

TECHNICAL EXPERTISE

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• Navigate through Quality and Warehouse Management Systems with training – CQ, Tecsys Elite, WebCTRL.
• Intermediate Microsoft Office skills: Outlook, Excel, PowerPoint.
• Knowledge of applicable state and federal laws for warehousing and distribution of pharmaceutical and medical devices, as well as the ability to interpret and apply rules and regulations including FDA, DEA, PDMA, DSCSA.
• Intermediate public speaking and presentation skills.
• Ability to track and present quality metrics/trends.

ADDITIONAL EMPLOYMENT REQUIREMENTS

• Must be able to successfully pass all preliminary employment requirements (i.e., background check and drug screen).
• Must be able to travel up to 20%.
• Must have a valid driver’s license.

PHYSICAL/MENTAL/VISUAL DEMANDS

• Work is light to medium in nature with frequent walking to perform assigned tasks.
• Must be able to safely conduct occasional lifting of 20 to 50 lbs.

WORKING CONDITIONS

• Activities occur within a typical office environment.
• 10% of time is spent in a warehouse setting.

EQUIPMENT OPERATED

• Equipment:  Laptop computer, cell phone, fax machine, copier, and desk phone

• Systems: Outlook, Excel, Word, PowerPoint, and CQ (Quality Management Software)