Job Description
Job DescriptionOverview: 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: Manufacturing Deviation Investigator / Sr. Quality Records InvestigatorLocation: Houston, TX - 77047Duration: 6 Months Job Type: Contract Work Type: Onsite Shift: Monday to Friday - 08:00 AM to 05:00 PM
Summary The Deviation Investigator/Initiator Level III is responsible for the initiation, investigation and completion of Minor and low/medium severity Major process deviations unassisted, and the supervised completion of high severity Major and Critical process deviations with the aim at identification of root cause, determining Product Quality Impact (PQI) and implementation of corrective actions to prevent recurrence. Responsibilities
- Technical writing for the educated but uninformed reader, translate difficult and complex scientific events into a brief and cohesive report as a finished product.
- Accurately capture immediate actions and containment of the event, address comments from both internal and external clients on the compiled final report.
- Gathering Data from various sources across the site, performance of Root Cause Analysis (RCA) to determine the most likely cause of the deviation investigation, assessment of event for impact to Safety Identity Strength Quality Purity (SISQP), perform trending analysis, identification of Corrective and Preventative Actions to reduce deviation recurrence, performance of Risk Assessments, Causing Mapping, Interviewing.
- Management of multiple projects and timelines concurrently.
- Ability to adhere to standard timeline, and escalate actions appropriately for resolution in a timely manner.
- Participation in the Daily Management meetings to update leadership or current deviation statuses.
- Routine interaction with the customer, including compilation of Power Points to communicate investigational current status, Alignment meetings, facilitated reviews, CAPA discussions, Comments resolution.
- Work on the manufacturing floor for data gathering, observing of processes for investigations, and performance of associate interviews.
- Meeting Facilitation and participation, aligning internal review team and area subject matter experts on an agreed to investigational path forward.
- Complex Conflict resolution, problem solving in a cross functional setting, and ability to keep the meeting on track to achieve objectives of varying difficulty.
- Attendance and occasional leadership of the daily management system and participating/leading the deviation review board.
- Perform other duties as assigned.
Required Skills
- Prior experience in Technical writing and documentation
- Prior experience in performing in Deviation investigation and root cause analysis (RCA)
- Strong hands on experience with CAPA (Corrective and Preventive Actions) creation and follow-through
- Understanding of cGMP and pharmaceutical/biotech manufacturing
- Quality systems and deviation lifecycle management
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.