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Manufacturing Investigator
Ref No.: 18-02433
Location: Dayton, New Jersey
Position Type:Contract
Experience Level: 1 Years
Pay Rate : $ 20.00 /Hour
Job Category:Biotech/Pharmaceutical
Benefits:401K, Dental Insurance, Life Insurance, Medical Insurance, Vision Insurance
It is the Investigators responsibility to ensure that the investigations performed according to SOP of Aurolife Pharma LLC.
Essential Functions:
Chemist's responsibility includes:
1. Gathering Data from manufacturing deviations, performance of Root Cause Analysis to determine the most likely cause of the deviation, assessment of event for product/process impact, perform trending analysis.
2. Identification of Corrective and Preventative Actions to reduce deviation recurrence, performance of Risk Assessments, Causing Mapping, Interviewing Meeting facilitation and participation, aligning internal review team and area subject matter experts on an agreed to investigational path forward.
3. Accurately capture immediate actions and containment of the event, address comments from both internal and external audits on the compiled final report.
4. Complete the manufacturing investigations on time.
5. Prepare new SOP”s , revision of existing SOP's and training of manufacturing operators on SOP's.
6. Whenever required oversees monitors and coordinates Production activities (e.g. Granulation, Blending, Compression, and Coating) giving importance to individual members and overall team achievement for policy deployment objectives.
7. Works proactively in addressing potential issues and applies real-time problem solving skills when working towards resolution.
8. Provides regular and timely reports and interpretation of results to the Production Manager.
9. Review of manufacturing batch record as required
10. Follow company policies, cGMP's and Standard Operating Procedures.
11. Perform any and all additional tasks relating to the operation of the manufacturing department as requested.
12. Physical Work Activities and Exposure:
a. Work is regularly performed inside in a manufacturing environment.
b. Exposure to dust, odor, noise, and fumes.
c. The noise level is usually moderate.
d. If required lift and/or move up to 50 pounds and if required occasionally lift and/or move up to 75 pounds.
e. Frequent sitting, talking, or hearing.
f. Use hands to finger, handle, feel, or operate objects or controls.