Open Menu
Careers

Supervisor QA Compliance Investigations & CAPA

Location

Whippany, NJ, USA

Department

Quality Assurance

To apply for this job email your details to Dawn.Moynihan@cambrex.com.

Overview

Primarily responsible for ensuring 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. This position will interact with departments within Cambrex to critically evaluate quality systems in order to support process improvements.

Responsibilities

  • Provide leadership to Investigation Team in the investigations, deviations, complaints, and corrective and preventive action (CAPA) programs as assigned.
  • Manage the investigation, Deviation, Complaint, and APR systems.
  • Create meaninful metrics based on the available data to drive compliance and create compliance adherence score.
  • Engage and align with other diverse and dispersed organizations and functions, building teamwork.
  • Partner with others and lead and motivate the organization in driving continuous improvement and change, improving customer satisfaction.
  • Provide support during regulatory inspections and cleint audits as aplicable.
  • Provide inspection readiness support to the site-identification of compliance gaps and risks, and participation in the remediation process.
  • Participate in inspection preparation, and participate in regulatory inspections, defending Deviation/CAPA policies and practices.
  • Write clear, concise, and thorough investigations for quality events using quality risk management principles.
  • Write clear, concise, and thorough investigations for product complaints.
  • Perform RCA using industry standards, such as FMEA, 5 Whys, 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.
  • Manage CAPA and CAPA effectiveness processes. Work with cross function groups to verify CAPA implementation, effectiveness, and timeliness.
  • Track and trend quality events and complaint metrics.
  • Proactively identify possible quality events and initiate steps to prevent identified events.
  • Identify opportunities for continuous improvement.
  • Act as a QA liaison in cliient and internal project meetings.
  • Assist with development and writing of quality SOPs, documents, and/or reports as needed.
  • Provide support during during regulatory inspections and client audits.
  • Summarize and trend quality events within Annual Product Reviews.
  • Perform other duties as assigned.

Qualifications

Strong knowledge of cGMPs and experience in GMP processes and pharmacutical document review to understand and guide process improvements. Of particular importance, understand quality systems. Possess some knowledge of project management tools and has some experience leading cross functional teams.

  • Communication – speak clearly and persuasively in positive or negative situations; listens and gets clarification; respon well to questions; demonstrate group presentation skills; participate in meetings. Write clearly and onformatively; edit work for spelling and grammar; vary writing style to meet needs; presen numberical data effectively; able to read and interpret written information.
  • Leadership – exhibit confidence in self and others; inspire and motivate others to perform well; accountable for behaviors and their impact on others; effectively influence actions and opinions of others; accept feedback from others; give appropriate recognition to others.
  • Business Acumen – understand business implications of decisions; display orientation to profitability; demonstrate knowledge of market and competition; align work with strategic boals. Ability to prioritiz and respond to changing business demands.
  • Strategic Thinking – develop strategies to achieve organizational goals; understand organization’s strengths and weaknesses; adapt strategy to changing conditions. Critically evaluate 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. Apply risk management philosophy to business processes, decisions, and data.
  • Innovation – display original thinking and creativity; meet challenges with resourcefulness; generate suggesions for improving work; develop innovative approaches and ideas; present ideas and information in a manner that gets others’ attention. Appliy 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.
  • Must be able to remain sedentary for periods of time.
  • Bachelor’s degree (B.S) from a four-year college or university in engineering or sciences.
  • Advanced degree highly preferred.
  • 5+ years in a quality assurance investigations role in a cGMP-regulated environment.
  • Experience successfully leading event investigations, Root cause Analyss (RCA), and CAPA.
  • Must have technical experience writing and assessing deviations, investigations, comlaints, and Out of Specifications.
  • Must be able to analyze data/information and to assess and resolve complex problems.
  • Knowledge of products, equipment, processes, customner 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 US and international cGMP’s’, ICH, and other regulations applicable to clinical and commercial manufacturing.
  • Must be familiar with overall Product lifecycle and associated documentation.
  • Knowledge of operational processes and controls in non-sterile and sterile operaitons.
  • Experience in a contract development and manufacturing environment desirable.
  • Experience with Microsoft, Trackwise, and other documentation management systems.