The Senior Quality Associate - Technical Writing and Investigations ensures quality assurance and regulatory compliance throughout the investigation, deviation, and CAPA Management process while adhering to applicable regulatory statute and standards; to promote the safety, identity, strength, purity, and quality of the products while supporting the overall company business plan. Supports the Business Unit by providing necessary data, writing reports, and conducting research on various topics. Stays updated on best practices and quality trends and regulatory requirements
* Writes clear, concise and thorough investigations for quality events using quality risk management principles.
* Writes clear, concise and thorough investigations for product complaints.
* Perform RCA using industry standards, such as FMEA, 5Whys, Fishbone diagram.
* Identify CAPA to remediate and reduce identified risks.
* Work with cross functional teams to perform RCA, identify failure modes and propose appropriate CAPA.
* Perform Risk Assessments to assess impact to product quality safety and efficacy.
* Manages CAPA and CAPA effectiveness processes. Works with cross functional groups to verify CAPA implementation, effectiveness and timeliness.
* Tracks and trends quality event and complaint metrics.
* Proactively identifies possible quality events and initiate steps to prevent identified events.
* Identifies opportunities for continuous improvement.
* Acts as a QA liaison in Client and internal project meetings.
* Reviews and approves laboratory deviations and investigations.
* Assists with development/writing of quality SOPs, documents and/or reports as needed.
* Provides support during regulatory inspections and client audits.
* Summarizes and trends quality events within Annual Product Reviews.
* Other duties as assigned.
Strong knowledge of cGMPs and experience in GMP processes and pharmaceutical document review to understand and guide process improvements. Of particular importance understands quality systems. Possesses some knowledge of project management tools and has some experience leading cross functional teams.
* 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. 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.
* Leadership- Exhibits confidence in self and others; Inspires and motivates others to perform well; Accountable for behaviors and their impact on others; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
* Business Acumen - Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals. Ability to prioritize and respond to changing business demands.
* Strategic Thinking - Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Adapts strategy to changing conditions. Critically evaluates quality systems to propose best practices. Strong problem solving skills and analytical assessment for continuous improvement.
* Able to critically think, assess problems and collaborate to come to an appropriate resolution. Proactive and driver of continuous improvement operations. Applies risk management philosophy to business processes, decisions, and data
* Innovation- Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention. Applies risk management philosophy to business processes, decisions, and data
* To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
* Must be able to move about the facility
* May be required to wear personal protective equipment
* May be sedentary for extended periods of time
* Bachelor's degree (B.S.) from four-year college or university in engineering or sciences.
* Advanced degree preferred.
* 10+ years in a quality assurance investigations role in a cGMP-regulated environment.
* Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA.
* Must have technical experience writing and assessing deviations, investigations, complaints and Out of Specifications.
* Must be able to analyze data/information and to assess and resolve complex problems.
* Knowledge of products, equipment, processes, customer applications, quality systems, quality improvement tools, and problem-solving techniques.
* Additional certifications such as CQE, CQA, ASQ-Six sigma green belt or black belt desirable.
* Strong knowledge and understanding of U.S. and international cGMPs, ICH, and other regulations applicable to clinical and commercial manufacturing.
* Knowledge of operational processes and controls in non-sterile and sterile operations.
* Experience in a contract development and manufacturing environment desirable.
* Experience with Microsoft, Trackwise and other documentation management systems.
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