Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.
Job Title: Quality Records Investigator / Deviation Investigator/Initiator
Location: Houston, TX, 77047
Duration: 6 Months - Possibility to Extend
Job Type: Temporary Assignment
Work Type: Onsite
Shifts: Monday to Friday from 08:00 AM to 05:00 PM
Summary
The Deviation Investigator/Initiator is responsible for initiating, investigating, and completing Minor and low/medium severity Major process deviations independently, and supporting high-severity Major and Critical deviations under supervision. The role focuses on identifying root causes, assessing Product Quality Impact (PQI), and implementing effective corrective and preventive actions to ensure product quality, compliance, and continuous improvement.
Responsibilities
- Initiate, investigate, and complete process deviation investigations in accordance with established procedures and timelines.
- Conduct thorough Root Cause Analysis (RCA) using appropriate methodologies to identify underlying causes.
- Assess deviation impact to Safety, Identity, Strength, Quality, and Purity (SISQP).
- Perform trending analysis, risk assessments, causal mapping, and associate interviews.
- Accurately document investigations, immediate actions, containment activities, and final conclusions.
- Translate complex scientific and technical events into clear, concise, and cohesive investigation reports.
- Gather and analyze data from multiple sources across the manufacturing site, including on-floor process observations.
- Identify, develop, and track Corrective and Preventive Actions (CAPAs) to prevent recurrence.
- Manage multiple deviation investigations simultaneously while adhering to standard timelines.
- Participate in daily management meetings and provide status updates to leadership.
- Interface routinely with internal and external customers, including preparation of presentations and participation in alignment and review meetings.
- Facilitate and participate in cross-functional meetings, deviation review boards, and daily management systems.
- Support conflict resolution and problem-solving in complex, cross-functional environments.
- Perform other duties as assigned.
Required Skills
- Experience working directly on manufacturing floors in GMP environments
- Root Cause Analysis (RCA) methodologies
- Strong deviation investigation and documentation skills in a regulated manufacturing environment.
- Technical and scientific writing skills for regulatory and quality documentation
- Knowledge of SISQP and Product Quality Impact (PQI) assessments
- Risk assessment and trending analysis
- Ability to manage multiple projects and timelines
- Effective verbal and written communication skills
- Cross-functional collaboration and stakeholder management
- Attention to detail and compliance mindset
- Experience with high-severity or critical deviation investigations
- Meeting facilitation and leadership experience
- Customer-facing communication and presentation skills
- Conflict resolution and advanced problem-solving abilities
- Familiarity with deviation review boards and daily management systems
TekWissen® Group is an equal opportunity employer supporting workforce diversity. TekWissen is an emerging global human capital, recruitment and IT services organization. Operating since 2009, we draw upon more than a decade of staffing experience to deliver critical talent acquisition solutions and IT engagements for our clients. We’re founded on a culture that is passionate about delivering tailored solutions, that create lasting partnerships.
Our global footprint covers six countries: United States, Canada, Australia, India, United Kingdom and the Philippines. This allows us to work in close partnership with organizations and manage everything from global talent needs with demanding resourcing strategies, to single sites with lower recruitment volumes.
TekWissen® is an equal opportunity employer supporting workplace diversity.