Randstad R&D Technician in Round Lake, Illinois
location:Round Lake, IL
salary:$35.53 - $41.80 per hour
date posted:Friday, October 5, 2018
industry:Professional, Scientific, and Technical Services
Manufacturing Lead Investigator - Senior
The Lead Investigators responsibilities will be to lead and manage new and aging investigations and related reports to closure within the established timelines for the engineering and manufacturing department. Will conduct comprehensive investigations to determine potential product impact, identify root cause and implementation of corrective and preventative actions in accordance with established procedures and timelines.
60% - Influence the organizational control of Quality systems: Create/monitor/author deviations, Out of Specification (OOS) and Out of Tolerance (OOT) and environmental alert actions. Monitor GMP investigations progress and support process to closure Escalate conflicts that arise.
20% - Work cross-functionally to assess and analyze deviations and investigations to determine impact and root cause
10% - Identify, initiate and track corrective and preventative actions for investigations, OOS and OOT
10% - Track and identify Quality System and root cause trends and identify opportunities for operational improvements
Education & Qualifications
Bachelors in Science or a related discipline with 5 years of industry experience in a pharmaceutical/biotech
Minimum of 3 years related experience in the manufacturing of biologics, pharmaceuticals or devices preferred
Previous technical writing experience preferred
Strong written and verbal communication skills
Demonstrate high-level of professional and business judgment when communicating with cross-functional teams and others at all levels of the organization
Must be proficient with Microsoft Office applications, including Word, Excel and Power Point.
Experience with more advanced document management applications a plus (including but not limited to TrackWise and SAP)
Ability to manage numerous priorities simultaneously Lead problem resolution meetings/teams effectively
Ability to shift priorities to meet required deadlines
Effectively communicate issues cross-functionally in a timely manner
Thorough understanding of biopharmaceutical manufacturing
Comprehensive understanding of industry regulations and cGMP compliance
Ability to apply industry regulations to decision making process
Excellent presentation skills.
Strong problem-solving skills and attention to detail
Facilitates, consults and collaborates with cross-functional teams including but not limited to Facilities and Engineering, Manufacturing Sciences & Operations Support, Quality, Validation and Operational Excellence & Training and Health, Safety & Environment.
Medical, Dental, and Vision Insurance
401K Plan with Company Match
Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.