Teams of Integrated Commissioning & Qualification Corporation (ICQ) Consultants have played a central role in the development, implementation and execution of various quality by design systems as well as the commissioning and qualification of multiple manufacturing plants in the New England area and elsewhere, including some of the world’s largest biotechnology facilities. Now due to our ever increasing client base we are looking for other professionals to join our team.
ICQ offers some of the most competitive benefits and wages in our segment of service providers which include the following:
- Short term / Long Term Disability – Paid 100% by ICQ
- Life insurance – Paid 100% by ICQ
- Blue Cross Blue Shield Health Insurance, Dental and Vision Plan – Paid 100% by ICQ
- Paid time off for Holidays, Sick Time and Vacation
- 401K with a 100% match to the first 4%
…and much more. There’s a reason we are one of the largest and most sought after CQV suppliers in the Northeast and now Southeast. Contact us and see what you have been missing…
GENERAL RESPONSIBILITIES AND REPORTING
These positions report to the assigned manager and have responsibilities for developing and execution of commissioning and qualification protocols, including test functions, and sampling. Must maintain compliance with the company’s Standard Operating Procedures and Policies. Adherence to timelines and deliverables a must.
- BS/BA degree in Biology, Biochemistry, Chemistry, Engineering or related experience in FDA-regulated industries working in QC, Manufacturing, Engineering, QA and/or Validation.
- Knowledge of FDA requirements, including cGMP’s, Quality System Remediation and Quality by Design, ICH-Q9, ICH-Q10, ASTM E-2500 principles.
- Experience or a demonstrated ability to perform the responsibilities of the position in leading, planning, and execution of projects involving in one or more of the following:
- 3 to 5 years QC Lab Validation Experience.
- 2 to 5 years Cleaning Validation and/or Sterilization
- 2 to 5 years Commissioning, Qualification and Validation of Utilities, Facilities, Processes and Process Equipment
- Develop and execute commissioning/validation plans, test plans, validation protocols, and procedures.
- Customarily and regularly exercises discretionary powers and independent judgment in performing the job.
- Work as a leader, part of commissioning/validation team, or independently to develop protocols and procedures, execute same including test functions, sampling and calibration.
- Responsible for developing new business opportunities at assigned client sites.
- Communication with management, clients, and project team members.
- Participate in training to ensure continued accreditation.
- Other tasks as required by department management.
- Travel may be required.
- Research and interpret client- and vendor-supplied documentation in order to write documents.
- Research and interpret client- and vendor-supplied documentation in order to write documents
DESIRED SKILLS AND EXPERIENCE
- QC Lab Commissioning/Qualification/Validation
- Cleaning Validation
- Commissioning, Qualification and Validation Generalist (Facilities, Utilities, Process Equipment etc.)
- Strong Attention to Detail
- Proficient at MS Word and MS Excel
- Excellent Communication Skills
- Ability to handle many tasks with limited direction
- Ability to deliver results is a must
- Demonstrated interest in continued professional development
- Demonstrated interest to provide a high level of customer support
Join our network, follow us and share this on LinkedIn, Google +, Twitter and Facebook so you can see other new and exciting news and discussions being posted by ICQ Consultants. Or visit our website and get and in depth view of what we are all about: http://icqconsultants.com.