Compliance Specialist jobs in Brockton, MA

Summary
ADPS is looking for a Quality Compliance Specialist to support a client in Norwood, MA. The candidate will participate in preparation activities for clinical partner audits and site readiness for inspections.
Key Responsibilities

• Participate in Risk Assessment activities, applying Phase appropriate guidance for engineering deliverables for clinical production
• Provide oversight and guidance for development of proactive approaches for the Continuous Improvement Plan (CIP) items
• Partner with functional areas for progress of the Clinical Deviation Tracker,
  Provide expertise for CAPA and Quality Event oversight of investigation to progress through the systems
• Participate in preparation activities for clinical partner audits and site readiness for inspections
• Provide guidance and input for Clinical Quality Projects
• Perform Phase appropriate assessments
• Participate in critical investigations
• Offer expertise and guidance to support growth of a mature clinical program
• Quality on the floor support offering mentorship to staff

• The successful candidate must have experience in a biotech or pharmaceutical development environment and knowledge of cGMP quality systems
• 5- 10 years of experience in the pharmaceutical/biotech industry within Quality Assurance or Quality (Assurance) exposure
• Working knowledge of relevant FDA, EU, ICH guidelines and regulations
• Excellent judgment and ability to communicate complex issues in an understandable way
• Outstanding communication skills (verbal and written)
• Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation.

• Continuous Learning –Assesses own strengths and weaknesses. Pursues training and development opportunities. Seeks feedback to improve performance. Shares expertise with others. Strives to continuously build knowledge and skills.
• Culture - Supports a culture of excellence. Contributes to a collaborative environment that rewards teamwork, mentorship, best-in-practice development, and pride in workmanship.
• Customer Services – Displays courtesy and sensitivity. Manages difficult or emotional customer situations. Meets commitments. Responds promptly to customer needs. Solicits customer feedback to improve service.
• Planning and Organizing – Prioritizes and Plans work activities. Uses time efficiently. Plans for additional resources. Integrates changes smoothly, Sets goals and objectives. Works in an organized manner.
• Teamwork – Balances team and individual responsibilities. Contributes to building a positive team spirit. Exhibits objectivity and openness to others’ views. Gives and welcomes feedback. Puts success of team above own interests.
• Use of Technology – Demonstrates required skills. Adapts to new technologies. Keeps technical skills up to date. Troubleshoots technological problems. Uses technology to increase productivity.
• Language Ability - Read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Write routine reports and correspondence. Speak effectively before groups of customers or employees.
• Mathematical Ability - Work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Apply concepts such as fractions, percentages, ratios and proportions to practical situations.
• Reasoning Ability - Apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Deal with problems involving several concrete variables in standardized situations.
  

The Company
DPS Group is a global EPCMV firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. DPS is dedicated to delivering successful projects with a ‘client-first’ mentality and personal touch across a range of market sectors: Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up.



DPS Engineering Inc. is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. DPS does not discriminate in employment opportunities or practices on the basis of: race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.

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