A Few Words About Us
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Responsibilities:

1. Managing laboratory testing of raw materials, in process materials and finished product in support of the manufacturing schedule and to ensure timely delivery of product to customers. 

2. Ensuring that all laboratory test methods and procedures are executed in compliance with specifications and standards. Additionally, working in the development, writing, updating and review of test methods, SOPs, protocols, and specifications as required. 

3. Serving as Subject Matter Expert for testing methodology. Using knowledge of scientific techniques to independently troubleshoot product quality issues of a complex nature with a sense of urgency. 

4. Ensuring that all laboratory instruments and systems and software are maintained in accordance with procedures and standards. 

5. Ensuring that all laboratory activities are conducted in accordance with government regulations and safety requirements as well as all Enterprise, Sector and Company policies. 

6. Reviewing and approving quality records (e.g. non-conformance, CAPA) related to laboratory events. 

7. Driving the investigation of non-conforming laboratory test results as well as reviewing and approving laboratory OOS and OOT events including related quality records and investigation reports. This will include ensuring that the reports are consistent, complete and in alignment with applicable standards and procedures including appropriate content and references. 

8. Escalating quality issues to management 

9. Monitoring laboratory quality data and metrics on a regular basis to ensure that appropriate investigation, corrective action, and/or escalation is conducted as required for recurring trends involving products, methodologies, instrumentation and scientists. This includes taking appropriate action to drive timely resolution of laboratory nonconformances and CAPA to meet applicable goals. 

10. Monitoring data from Contract Laboratories including non-conforming test results. Interfacing with contract laboratory during the laboratory investigation process. 

11. Leads, develops, trains and coaches lab associates within the laboratory. This includes ensuring that associates have appropriate resources and support to execute testing in accordance with procedures, standards and regulations as well as ensuring that all relevant core competency training modules are completed by the laboratory personnel. 

12. Maintaining up to date knowledge of the company’s products and manufacturing processes related to relevant laboratory testing. 

13. Providing audit support (front room, back room and SME). 

14. Working with cross functional teams to successfully resolve audit findings, product non-conformances, customer complaints, to execute Corrective/Preventive Actions and/or to improve product design. 

15. Monitoring departmental activities to ensure that laboratory personnel follow all company guidelines related to Health, Safety and Environmental practices. 

16. Ensuring the timely completion of document reviews and approvals for document changes within their area of responsibility 

17. Participating in budget planning for the laboratory. 

Major Responsibilities may include: 

1. Managing stability testing including the escalation of stability alerts to management 

2. Working closely with R&D in support of development, troubleshooting, validation and transfer of test methods to a commercial QA/QC laboratory.

OTHER RESPONSIBILITIES: 

1. Work in team environment behaving in a CREDO based respectful manner 

2. Comply with all federally regulated programs. 

3. Adhere to J&J environmental and safety policies and guidelines. 

4. Comply with all job specific safety procedures and utilize PPE when necessary. 

5. Comply with quality system requirements as defined within procedures and instructions. 

6. Use test equipment (GC, HPLC, FTIR, etc) where applicable. 

7. Utilize applicable software systems as needed for the job (e.g. ComplianceWire, ADAPTIV, etc.) 

8. Consistently meet required work performance targets (RE’s), if applicable 

9. Support LEAN and Six Sigma Initiatives. 

10. Support Maintenance Excellence (ME2) including 6S and Operator Asset Care. 

11. Accurately complete records as defined within the job procedures (e.g. manual and/or electronic documentation). 

12. Perform other work-related duties as assigned by supervisor. 

13. Consistently meet required Training due date targets. 

  Skills and Qualifications:

1. A Bachelor of Science Degree is required. A Master of Science or PhD is preferred. 

2. Greater than 10 years’ experience in a GMP laboratory with Bachelor of Science Degree is preferred 

3. 5 to 7 years’ experience in a GMP laboratory with Master of Science Degree or PhD is preferred 

4. Ability to perform in a leadership role and to effectively manage people 

5. Good interpersonal, organizational and oral and written communication skills 

6. Must be able to interact well with peers and colleagues 

7. Self-motivated

 Skills and Qualifications:

1. A Bachelor of Science Degree is required. A Master of Science or PhD is preferred. 

2. Greater than 10 years’ experience in a GMP laboratory with Bachelor of Science Degree is preferred 

3. 5 to 7 years’ experience in a GMP laboratory with Master of Science Degree or PhD is preferred 

4. Ability to perform in a leadership role and to effectively manage people 

5. Good interpersonal, organizational and oral and written communication skills 

6. Must be able to interact well with peers and colleagues 

7. Self-motivated