Supervisor, Qa Internal Operations

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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.
JOB DUTIES

• 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

PROFESSIONAL SKILLS

• 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

EXPERIENCE

• Experience working in Manufacturing, Quality Assurance, and/or Quality Control groups which support the manufacturing of pharmaceutical products
• Exposure to RCA, technical writing, and working with quality related investigations
• Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
• Knowledge and ability to apply basic scientific principles to solve operational, as well as routine quality tasks
• Previous supervisory or team leadership experience preferred

EDUCATION

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

QUALITIES

• 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

PHYSICAL REQUIREMENTS & MENTAL DEMANDS

• Requires the ability to lift, carry, push or pull light weights (up to 20 pounds
• Frequent reading, writing, and verbal communication
• Able to translate ideas to actual concepts and processes
• Proven ability to manage multiple projects (duties) simultaneously
• Able to work in a highly complex environment with competing demands and priorities

COMMUNICATIONS & CONTACTS

• Cross functional staff, members of management, internal and external clients, members of the Quality organization

MANAGERIAL & SUPERVISORY RESPONSIBILITIES

• Responsible for leading and delegating daily activities in which the QA Operations Associates are responsible for performing. Ability to observe, identify potential issues, and resolve satisfactorily. Ability to provide hands on leadership, coaching, and coordination of needed actions with a focus on achieving goals and deliverables. Must be able to manage, plan and multi-task with minimal guidance. This position is a working-supervisor level position.
• Support senior management as needed.

TRAVEL

• < 10%

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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.