- Authoring Comprehensive Investigations: 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 decision-making.
- Guarantee all activities comply with regulations, update procedures, and provide guidance to staff on compliance matters.
- Required - BS degree in science or equivalent 4+ years of relevant experience
- Prior GMP experience (at least 3-5 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.
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QC Analytical Investigator - Boston, United States - DPS Group Global
Description
ADPS is looking for a talented and experienced QC Analytical Investigator to support leading and owning analytical investigations, including phase I laboratory investigations, phase 2 manufacturing investigations, and phase 2 extended laboratory investigations. The scope of work will require writing analytical investigations and holding stakeholder meetings with QC, analytical development, manufacturing, and quality assurance to progress the investigations and close the quality records with effective CAPAs within the quality record due date. The ideal candidate will possess a strong QC Analytical Investigation background and a minimum of 4-5 years of biotech/biopharm experience.
Responsibilities
Skills And Qualifications
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.
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.
