Sr Ops Quality Eng

Endo • Raleigh, NC

1d • Hybrid

About The Position

The Sr. Quality Engineer has responsibility for interpreting and applying the applicable regulations and Quality Systems, and developing and implementing standard operating procedures (SOPs) and policies. In a cGMP manufacturing setting, provides Process / Quality Engineering support to all areas of the facility to ensure delivery of the highest quality product to the customer. The Sr. Quality Engineer will provide statistical and process support to assist with continuous improvement activities.

Requirements

• B.S. degree in Engineering or Science or a related field
• Minimum of 5 years’ experience in QA/pharmaceutical manufacturing environment
• Statistical analysis (Excel, Mini-tab, other statistical software).
• Must have strong computer skills/knowledge and statistical skills as applicable to Quality/Process Control.

Nice To Haves

• Knowledge of regulations associated with ICH Guidelines (Q7, Q8, Q9, and Q10), FDA, EMA, USP, EP, and JP.
• Direct interactions with regulatory inspections.
• Strong technical, oral, and written communication skills.
• Able to speak, read, and write the English language.
• Knowledge of Six Sigma Tools or certification.
• Good project management, problem solving, team building, and negotiation skills.
• Good facilitation, presentation, and prioritization skills.
• Ability to manage multiple projects.
• Knowledge of SPC, DOE, FMEA, Six Sigma and Lean Manufacturing.
• Individual must be self-motivated, able to achieve results with minimum supervision.
• Command Skills, Action Oriented, Conflict Management, Customer Focus, Timely Decision Making, Functional / Technical Skills, Presentation Skills, Problem Solving, Priority Setting, Dealing With Ambiguity, Written Communication
• CQE certification preferred
• CQA certification preferred

Responsibilities

• Provides input into regulatory filings as well as guidance for the various elements of the Quality System, including but not limited to the following: Annual Product Review, Process control, Change Control, Validation, Product complaints, Audits, Internal Audits, Supplier Quality, OOS, CAPA and identification/recommendations for continuous improvement opportunities (internal/external).
• Applies the appropriate statistical tools to analyze data, identify root cause and develop corrective actions for effective problem resolution of moderate to difficult scope and complexity.
• Provides site guidance and input to Regulatory Affairs to support all required regulatory filings.
• Manages the site Internal Audit program.
• Provides guidance and training to Quality Department personnel in all applicable Quality Systems.
• Leads compliance efforts for the site.
• Responds to customer inquiries.
• Primary backup for Product Release.
• Prepares Annual Product Reviews.
• Prepares Management Reviews.
• Gauges monthly metrics.
• Provides direction and leadership for quality system improvements and for benchmarking of other sites to establish and implement best practices.
• Provides validation guidance and support for computer systems, production processes, and both production and laboratory equipment.
• Participates in continuous improvement activities as required.
• May lead continuous improvement activities (e.g. kaizen).
• Works within production teams, develop data trending models using appropriate statistical methods and deploy use of them.
• Analyzes trends related to various activities and identify root causes and areas for improvement.
• Utilizes output of trend analysis to initiate investigations and or corrective/preventive action projects.
• Assesses manufacturing and support processes to identify and implement quality minded efficiencies and improvements.
• Leads or participates in risk analysis activities (FMEA) for changes to production or design processes.
• Uses process mapping tools to define critical control points and recommend alternatives to reduce risk of defects.
• Oversees cross functional teams for complaint investigation and resolution.
• Generates final complaint investigation reports.
• Leads investigation efforts and accurately document investigation plans, supporting data, and conclusions.
• Leads corrective and preventive action projects.
• Participates on extended core teams as a QA representative.
• Develops sampling plans, as needed.
• Provides change management guidance and support.
• Provides internal / external audit support.
• May assume the Lead Auditor role.
• Serves as a subject matter expert for Regulatory and Customer audits.
• Conducts New Employee orientation.
• Provides supplier quality oversight, including technical support for supplier selection and supplier quality evaluations as well as the development and management of supplier corrective action plans.
• Works closely with suppliers to ensure quality expectations and strengthen supplier relationships.
• Participates in a certified 5S Workplace System to ensure good housekeeping and organization.
• Prioritizes and plans workload and team assignments to meet all internal and external customer needs for maximum efficiency and accuracy.
• Effectively trains others in a positive manner.

Benefits

• We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 501-1,000 employees