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The opportunity
POSITION SUMMARY
    
This position is responsible for the evaluation of Investigations for Operations and Laboratories; CAPAs, Effectiveness Checks, Protocols and Reports from but not limited to: Analytical Method, Equipment Qualifications, Process Validations.  Also, review and approve Change Control System, LIMS/MES/SAP changes, Electronic Document Management System for the procedures, forms and any documentation supporting the sites in strict accordance with all Standard Operating Procedures, Current Good Manufacturing Practices, Company policies and procedures, and Food and Drug Administration requirements governing the manufacture of pharmaceutical products.  Responsible for identifying trends key areas an indicator from production and laboratories for implementation of corrective and preventive measures. This role requires close collaboration with cross-functional teams to ensure a seamless and successful achievement of Key Performance targets.

ESSENTIAL AREAS OF RESPONSIBILITY 

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments. 

Work closely with other Quality Engineer team members on activities for EDMS, Investigations, CAPAs, Effectiveness Checks, Protocols, Reports for Equipment Qualifications, Process and Method Validations and the Change Controls associated.
Work closely with QC and Production for LIMS, MES, SAP changes.
Work closely with Project Managers, R&D, Regulatory Affairs, Quality Control, Quality, Operations and Supply Chain teams for documents review and approval in a coordinated effort, and alignment on site priorities and  launch objectives to ensure a seamless and successful KPIs.
Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
Reviews and approves production and process control Standard Operating Procedures (SOPs) that are drafted, reviewed and approved by other organizational units.
Support the identification, investigation, closeout of deviations and Corrective Actions & Preventive Actions.
Coordinates with Operations to ensure compliance with and understanding of CGMPs, Company policies and practices, and safety procedures.
Support inspections and audits to ensure compliance with CGMPs, SOPs, Company practices and procedures and governmental regulations.
Prepare the monthly and quarterly Quality Council report for Deviations, CAPAs, CC, and any other Quality System required.
Provides support, in the areas of problem resolution and TLMS projects.
Ensures project deadlines and performance standards are established and met.
Responsible for performing additional related duties as assigned.
Responsible for completing all training requirements and maintaining 100% compliance with all assignments.   
Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), and Standard Operating Procedures (SOP’s) instructions. 
Responsible for performing additional related duties as assigned.
 

Your experience and qualifications
Education/Certification/Experience:

Requires Bachelor Degree preferably in Science, Engineering, Master Degree also preferrable from an accredited college or university, with a minimum of 5 years relevant progressive experience in the pharmaceutical industry.
Preferably in a pharmaceutical manufacturing environment or related field.

Skills/Knowledge/Abilities:

Strong Project Management and organizational skills.
Analyzing and troubleshooting problems, identifying solutions, recommending and implementing methods, procedures and or/techniques for resolutions.
Responding to technical inquiries from management, peers, and regulatory agencies.
Communicating clearly and concisely, both, orally and in writing.
Operating scientific and personal computers.
Managing multiple projects, duties, and assignments.
Interpreting and applying Federal, state, and local policies, procedures and regulations.
Directing, coordinating assignments of the QA department personnel.
Establishing and maintaining cooperative working relationships with others.
Principles of TLMS, leadership, and training.
Principles of safety, worker’s compensation, OSHA, and related principles and practices.
Pharmaceutical principles, practices, and their application.
FDA, SOP, cGMP and other pertinent regulatory compliance and requirements.
Business and personal computer hardware and software applications.
Business English usage, spelling, grammar, and punctuation.
Business, scientific and personal computer hardware and software applications.
Skill levels in MS Office including proficiency in Word, PowerPoint, Excel and SharePoint.  
Must be able to maintain the highest levels of confidentiality, integrity and discretion. 
Excellent verbal, written, and interpersonal skills required. 

Problem Solving:

Proactively works on problems of a moderate to complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.
Seeks out all resources when selecting methods and techniques for obtaining results.
Acts independently and proactively to recommend and administer methods and procedures for problem resolution.
Able to identify solutions to general problems through collaboration and creativity.

PHYSICAL REQUIREMENTS:
Frequent:

Sitting for extended periods of time at work station or mobile equipment
Walk Operations areas frequently.

Visual Acuity:

Close visual acuity to perform activities such as computer work, preparing and analyzing data, extensive reading, and visual inspection involving small defects, small parts and/or operation of machines (including inspection), using measurement devices and/or assembly or fabrication of parts at a distance close to the eyes.

WORKING ENVIRONMENT:

Exposure to low to moderate noise levels
Fast paced environment.
Able to manage multiple priorities and ensure appropriate follow-ups. 
Highly organized and excellent time and project management skills with the ability to juggle a wide range.
Ability to work under pressure and meet deadlines.