Supervisor, QA

Quality & Compliance Chestnut Ridge, New York


Description

 

Job Summary - a concise overview of the job

The Supervisor QA, under limited management, ensures compliance with cGMP and company policies, procedures and specifications. Responsible for supervising Quality Assurance Associates activities of Quality Operations include batch record stage review, raw material and bulk product releases, production quality inspection/ sampling/testing, shop floor monitoring, etc. with cGMP and company procedures, state, federal, DEA, local law.

All incumbents are responsible for following applicable Division & Company policies and procedures.

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

Quality operations supervision within a single site.

 

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Quality Assurance Management

§  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 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.

§  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.

50%

Documentation & SOPs

§  Reviewer of executed packaging and manufacturing batch records.

§  Author and review SOPs relevant to the job duties.

§  Initiate deviation reports and supports investigative process.

20%

Compliance

§  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.

20%

Staff Development

§  Provides guidance, training, cross-training, coaching and work assignments for QA Associates.

§  Selects, develops, evaluates personnel to ensure efficient operation of QA function.

10%

Total

100%

 

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and  certifications required for the job

§  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

Proficiency in a body of information required for the job, e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

§  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

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific, e.g. coaching, negotiation, calibration, technical writing etc.

§  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.

Physical Requirements

Physical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

§  Extended periods of sitting, standing and walking; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and taste or smell, looking at monitor, and moderate noise levels.  Work is performed in a cGMP environment.

 

Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.