Deviation Investigator - The Staffing Resource Group, Inc

Title: Deviation Investigator / Technical Writer III

• Location: Houston, TX
• Industry: Pharmaceutical
• Hours: Mon - Fri 8am - 5pm
• Salary: $50.00 hr.
• Employment Type: Long Term Contract
• This is an on-site position; candidates should not expect a remote job and must be local with a reasonable commute. Possibility to work remotely 1-2 days a week in the future but should be local with a reasonable commute to be onsite 5 days without issue.

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire, and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to match professionals rapidly and precisely to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

Environment: A global leader and trusted supplier in the pharma, biotech, and specialty ingredients markets. Headquartered in Basel, Switzerland, the company is focused on advanced manufacturing, high-quality control systems, regulatory expertise, and research and development (R&D) capabilities. The company s products and services include active pharmaceutical ingredients (API), stem cell therapies, drinking water sanitizers, vitamin B compounds, organic personal care ingredients, industrial preservatives and microbial control solution to combat viruses, bacteria and other dangerous pathogens.

Job Summary:

The Deviation investigator Level is responsible for the initiation, investigation of any Minor, Major, or Critical process deviations aimed at identification of root cause, determining Product Quality impact (PQI) and implementation of correct actions to prevent recurrence. Additional duties include lead representative during audits, project meetings with clients, and daily management meetings when applicable

Candidate Must Haves:

• Investigation/Deviation experience will be a must but needs to be combined with any Biotech experience in either MFG/QC
• Experience with RCA tools is a big plus
• Trackwise experience a plus
• CAPA identification and development a plus

• 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.
• Mentoring and training of Deviation Investigator / Initiators Levels 1 and 2.
• Perform other duties as assigned.

• 3+ years of experience
• Investigation/Deviation experience will be a must but needs to be combined with any Biotech experience in either MFG/QC
• Experience with RCA tools is a big plus
• Candidates must be local to Houston, able to work onsite
• Strong organizational skills and record keeping with the ability to work overtime when needed.
• Ability to engage and interview co-workers to obtain relevant information pertaining to investigations.
• Strong attention to detail and organizational skills.
• Strong communication skills (written and oral).
• Independent and self-motivated.
• Familiarity with cGMP quality systems.
• Ability to read and comprehend GMP documents (i.e. SOPs, logs, and Batch Records).
• Change promoter.
• Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, Powerpoint).

Education:

Bachelors - Life Sciences or Engineering

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