Job description

Overview:

TekWissen group is a workforce management provider throughout the USA and many other countries in the world. 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 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.

Description:

• 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.

Qualifications

Education

• AS/BS in Biotechnology, Biology, Chemistry, Engineering

Work Experience

• Technical Investigating - 0-4 years
• Manufacturing - 0-4 years

Skills

• 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).

Competencies & Behaviors

Agility

• Learns from experience, errors and setbacks.
• Willing to take on new challenges, takes steps to adapt thinking and behavior to support change.
• Challenges the status quo and looks for opportunities to make improvements in their area of the business.

Business Acumen

• Seeks to understand the corporate strategy and how their business area contributes to the company’s success.
• Understands the impact of his/her own actions on their business area.
• Expresses ideas that will improve their business area.
• Uses knowledge of their business area to make accurate and timely decisions.

Collaboration

• Works in partnership as an active member of the team and cross functional groups.
• Generously shares information and knowledge with others across the team.
• Demonstrates an openness to different perspectives and ideas.
• Champions and role models the values of diversity and inclusion through everyday interactions.
• Treats all co-workers and customers professionally and with respect.

Customer Focus

• Understands what internal customers need from them to deliver in their respective role.
• Demonstrates an openness to receiving customer feedback.
• Takes action to enhance customer satisfaction within the scope of their roleunder guidance by supervisor.

Driving Results

• Consistently delivers on assigned goals and monitors progress together with their supervisor.
• Demonstrates persistence and motivation to overcome obstacles and challenges.
• Ensures quality standards are maintained while delivering results.
• Plans, prioritizes and organizes work to deliver on time for both individually assigned and Team oriented projects.

Leadership

• Creates a positive work environment and demonstrates high integrity.
• Ensures clear and direct 2-way communication with the rest of Deviation Investigation Team.
• Supports others in taking responsibility for a safe environment.
• Steps forward and takes personal accountability for outcomes resulting from choices, behaviors or actions.
• Seeks feedback, reflects on their own development needs in order to improve continuously.

Responsibilities

Quality

• Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.

Safety

• Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site. Employee owns their own safety and the safety of others.

TekWissen® Group is an equal opportunity employer supporting workforce diversity.

Job Types: Full-time, Contract

Pay: $48.00 - $50.00 per hour

Application Question(s):

• How many years of experience do you have in initiation, investigation and completion of deviations?
• How many years of experience do you have in with CAPA and Root Cause Analysis (RCA)?
• How many years of experience do you have in the cGMP background in a pharma or biotech industry?

Work Location: In person

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