Supervisor, QA Internal Operations

PCI Services•Bedford, NH

34d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

ASQ certification Highly 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

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