Job Summary - a concise overview of the job
Member of the Quality group providing support for various aspects of Development, Phase I-IV clinical, scale-up activities and commercial manufacturing, testing and release, as applicable. The Quality Specialist assists with internal and external quality operations and systems, such as facility/equipment, utilities, materials, production, laboratory, packaging/labeling, and general compliance as applicable, and helps assure compliance with current domestic and international GMPs and regulatory agencies. The Quality Specialist may monitor, track and trend Non-Conformances, CAPA and other quality systems, assesses the risk level associated with Non-Conformances and escalate the issue to management. This role is responsible for initiating self-audit checks and evaluation of CAPA effectiveness checks. Additionally, the Quality Specialist is responsible for preparing materials for inspection readiness and management review.
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.
§ Scope covers Horsham, PA internal manufacturing sites (all Horsham based GMP functions/departments; Quality oversight for implementation of all electronic Quality Systems and Manufacturing Site IT Systems , including manufacturing, labs, building management systems, etc.).
§ Responsible for working with Endo departments and suppliers to identify and correct issues; Assures that Endo complies with company procedures as well as Health Authority regulations.
§ Assists all levels of management and suppliers to accomplish all regulatory compliance objectives.
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
Quality Documentation/Report Review
§ Prepares and/or reviews controlled documents (e.g. SOP’s) required for compliance.
§ Completes assigned duties and responsibilities (filing, etc.).
§ Assists with decisions that require developing options to solve basic to moderate issues.
§ Assesses risk level associated with NCRs, and escalates to management.
§ Assists with various aspects of development, management, harmonization and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations and company quality standards in support of cGxP activities.
§ Initiates communication of due dates for Quality Systems (NCRs, CAPA, Complaints, etc.) to ensure they are completed on time.
§ Contributes to various aspects of quality systems, such as Change Control, Deviations, Investigations, and CAPA systems to assure compliance and timely and accurate completion of reported events.
§ Initiates self-audit checks and evaluates CAPA effectiveness checks.
§ Prepares materials for inspection readiness and management review.
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ Associate’s degree in science or engineering with 5+ years’ experience in pharmaceutical / biopharmaceutical industry OR
§ Bachelor’s degree in above fields with 3+ years’ experience in pharmaceutical / biopharmaceutical industry OR
§ Master’s degree in above fields with 1+ years’ experience in pharmaceutical / biopharmaceutical industry.
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
§ Working knowledge of all current state, federal and local standards and regulations, e.g., cGMP, OSHA, and DEA.
§ Working knowledge of 21-CFR-210, 21-CFR-211 and ICH Guidelines.
§ Technical and quality background related to pharmaceuticals.
§ General understanding and knowledge of cGMP regulations
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.
§ Strong verbal and communication skills required.
§ Attention to detail required.
§ Demonstrated excellent interpersonal skills and flexibility.
§ Ability to handle multiple priorities in a fast paced environment.
§ Good writing skills.
§ Strong organizational skills.
§ Ability to build peer relationships.
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
§ Routine office work (sit/stand); no travel requirements.
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.