Quality Deviations Investigator II

Quality Deviation Investigator II

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients' lives with the pharmaceuticals we develop and manufacture.

We proudly offer

• Generous benefit options (eligible first day of employment)

• Paid training, vacation and holidays (vacation accrual begins on first day of employment)

• Career advancement opportunities

• Education reimbursement

• 401k program

• Learning platform

• And more!

Summary:

The Quality Deviation Investigator (QDI) II is responsible for leading investigations to ensure the written report contains technical merit and completeness according to regulatory expectations. This position will cross-functionally collect necessary data and information associated with manufacturing and laboratory deviations. This position will lead root cause analysis sessions with site SMEs and determine the associated corrective action to prevent the variation from recurring. This person will be a crucial player in the Quality Assurance Investigations team and a champion for quality priority principles and compliance within the Operations organization. This position reports directly to the Quality Investigations Manager. Additionally, the QDI II provides mentorship and guidance to QDI I's.

Essential Duties and Responsibilities:

• Develops a comprehensive understanding of the manufacturing processes and the associated risk management control strategy to identify process risks and critical controls around the related processing steps

• Provides consistent direction and timely completion of deviation investigations to ensure ongoing consistency for investigation reports that will stand alone during regulatory inspection through close collaboration with Manufacturing and Quality teams

• Collaborates with other leaders across the organization and assists in the continuous improvement and life cycle management of implemented GMP policies and quality management systems

• The investigation owner will lead complex and high impact investigation of deviations that occur in operations

• Authors and manage the inquiries to meet key timing commitments with well-investigated and well-documented deviation reports

• Work with quality assurance, quality control, operations, engineering, maintenance, calibration, safety, and supplier quality management to ensure the appropriate and timely determination of scope, product impact, root cause, and corrective actions

• Determines scope, product impact, root cause, and corrective actions for procedure deviations. Proposes and implements effective CAPA to eliminate these causes

• Determines appropriate preventative actions to prevent the reoccurrence of the deviation and author's deviations and conducts personnel interviews to determine the root cause of the variation

• Leads efforts to update SOPs or other official documents as required

• Foster a culture of continuous improvement through employee selection, training, and mentoring while focusing on operational efficiency and eliminating 'non-value-added' activities

• Provide a positive and equitable working environment emphasizing Curia Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance

• Complete any other duties/responsibilities assigned by senior management

• Read/interpret SOPs to ensure compliance

• Maintain up to date trainings

• Other duties as assigned

Education and Experience:

• Bachelor's Degree in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy, or related field of study or 4 years of relevant experience

• Minimum of three (3) to five (5) years' related quality deviation experience

• Experience with deviation or investigation management systems

• Experience in a cGMP-regulated manufacturing Pharmaceutical, Biotechnology and/or QA/QC

• Experienced in troubleshooting, investigation, and root-cause analysis in a cGMP environment

• Technical writing experience, writing deviations and CAPAs in the pharmaceutical/biotech environment, or related industry, preferred

• Proficient in Deviation Management (i. e. , TrackWise), preferred

Language Skills:

The ideal candidate should have the ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, they should possess strong written and verbal communication skills, along with effective presentation skills.

Mathematical Skills:

Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages. Candidates must possess a strong grasp of algebraic and geometric principles.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills:

The ideal candidate will possess a strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions. Essential skills encompass adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.

Other Skills and Abilities:

• Provides guidance and mentorship to team members

• Fosters a collaborative and positive work environment

• Champions change

• Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.

• Demonstrates strong attention to detail

• Comprehend and follow SOPs, cGMPs, and detailed instructions to successfully produce sterile quality products

• Document information, events, and cGMP manufacturing processes, accurately and completely

• Perform duties in an organized, detail-oriented manner. Work and communicate well with others in a team environment

• Ability to author and review standard operating procedures, on-the-job-trainings, and other controlled documents

• Ability to put complex thoughts and issues into writing so that an educated but uninformed reader can understand and make decisions based on the written investigation report

• Proficient in using the following methodology: 5-WHY,.