Qc Analytical Investigator - Framingham, United States - DPS Group
Description
Location:
Framingham, Massachusetts, United States
Employment Type:
Full-Time
Reference Code:
TSO824678MA
Date Posted: 10/Apr/2024
Years of Experience Req: 0 Years
Summary
Responsibilities
- Authoring Comprehensive _Investigation_s: Conduct thorough analyses, gather data, and document findings for various Quality Control deviations.
- Efficiently Managing the
Investigation Process:
Oversee from initiation to closure, coordinate stakeholders, establish timelines, and ensure the implementation of effective corrective actions.
- Skillfully Facilitating Discussions and
Gathering Information:
Engage stakeholders to gather insights and identify solutions for deviations.
- Utilizing Document Management Systems: Maintain accurate records using systems like Veeva, ensuring proper organization and version control.
- Collaborating with Cross-Functional Teams in QC, analytical development, manufacturing, and quality assurance to implement process improvements and address systemic issues.
- Analyze investigation data to identify recurring issues and present findings for informed decisionmaking.
- Guarantee all activities comply with regulations, update procedures, and provide guidance to staff on compliance matters.
Skills And Qualifications
- Required
- BS degree in science or equivalent 4+ years of relevant experience
- Prior GMP experience (at least 35 years), with a preference for quality control experience and leading OOS/invalid assay investigations.
- Experience with QC deviations, CAPAs, and change controls
- Must be experienced and demonstrate a high level of technical skill in technical lab operations and good understanding of related business.
- Related knowledge in Product Quality, Quality Control Lab Operation and Regulatory requirements is required.
- Ability to work independently to meet operational goals and business needs. Ability to make operational and business decisions with minimum direction from immediate supervisor.
Additional
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.
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.
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.
_LI-NH1
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