Supervisor, QA Internal Operations

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JOB DESCRIPTION:

Position Title:

Supervisor, QA Internal Operations

Location:

Bedford, NH Department:
Quality Assurance Internal Operations Reporting To:
Senior Manager QA Operations Responsible For (Staff):
Yes The Supervisor, QA Internal Operations is responsible for leading a team of QA Operations Associates responsible for on-the- floor support (Quality in Plant –or QIP) that provides 7 days a week QA oversight. This includes providing QA support in the manufacturing of clinical and commercial drug products/medical devices to ensure compliance with the principles and guidelines of cGMP. The QA Supervisor assists in assisting with quality systems, such as laboratory control, investigation management, materials management, document control and training to ensure control of the manufacturing process.

This position will actively partner with Manufacturing Operations, Visual Inspection, Materials Management, and other supporting departments to provide compliance and technical guidance to ensure quality issues are identified and resolved in a timely manner.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Oversee and provide QA support and guidance for daily cGMP manufacturing operations.

Coordinate with cross-functional teams to continually improve procedures with respect to area line clearances, labeling, packaging and material release.

Support scheduling activities by monitoring the production and visual inspection schedules and reviewing factors that may impact schedules.

Oversee and assist employees with product / material labeling and disposition functions, routine manufacturing area line clearances;
Assist with AQL Sampling and Inspection of Final Package Lots.

Review and approval of Blue Mountain documents and work orders

Complete staff performance reviews and align personnel goals to corporate initiatives.

Ensure all pertinent training is assigned to staff, and employee training is in good standing

Assist with review of master and executed raw material records and logbooks

Review of associated QC data to support facility and products

Participation in writing or revising Standard Operating Procedures, material control procedures, deviations, CAPA’s, and Quality Investigations when applicable.

Support external client audits at LSNE, and regulatory inspections

Obtain gown qualification for sterile manufacturing line clears

Maintain and evaluate current processes and procedures, and look for opportunities for continuous improvement

Other duties as assigned

Guide personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices

Assist QA Specialists in batch record reviews and generating CoAs

QUALIFICATIONS:

Required:

Bachelor’s Degree in relevant scientific discipline5+ years of pharmaceutical or biotech industry experience3+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production, or equivalent.

ASQ certification Highly preferred

Exceptional organizational skills and attention to detail

Ability to make risk based decisions and resolve issues with minimal guidance

Excellent interpersonal skills and the ability to communicate well orally and in writing

Proficiency in MS Office including Word, and Excel Excellent verbal and written communication skills required

Preferred:

Ability to supervise and lead people in a dynamic, fast paced work environment

Honesty, integrity, respect and courtesy with all colleagues

Creative with the ability to work with minimal supervision and balanced with independent thinking

Resilient through operational and organizational change

Ability to coach, train, and mentor others

Cross functional staff, members of management, internal and external clients, members of the Quality organization#LI-RS1

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