QC/ ELISA Scientist (ONSITE)
Please note that this is a 1 year contract position.
This position is in Raritan, NJ.
This is a day shift position, and you must be able to work between the hours of 6:
30 AM-6:
30 PM (actual shift - 7:
00 a.
m.
- 3:
30 p.
m.
) and have flexibility to work other shifts when necessary.
Weekends and overtime may be required.
Qualifications:
The QC Scientist I will be responsible for testing the stability and final product release of all OCD products.
This person will assure compliance with company standards and applicable regulatory agencies.
They will participate in failure investigations to help determine root cause, track and trend data, and identify and suggest process improvements to improve business measures.
A Bachelor's degree in Medical Technology/Medical Laboratory Scientist, Biology, Chemistry or related field and a minimum of 1-3 years' experience with QC, GMP, GDP, and medical device companies is required.
Experience with ELISA, SDS-PAGE, and electrophoresis.
Familiarity with the guidelines and regulations of FDA, OSHA, and ISO is preferred.
Manual dexterity to handle instruments, complete repetitive motions, and stand for long periods is required.
Diligent use of PPEs (Personal Protective Equipment) to limit exposure to bloodborne pathogens is required.
Excellent oral and written communication skills are required.
Proficiency with the Microsoft Office suite of products (Excel, Word, PowerPoint, Outlook).
Responsibilities:
Organizes and performs product release, stability and raw material testing under direct supervision.
Performs testing within established timelines and in accordance with current specifications.
Documents results clearly and accurately.
Interprets results by complying to appropriate specification requirements.
Perform data trending of critical product, process information and release test results to be used in SPC/ trend analysis.
The QA Scientist I will be responsible for performing release and stability testing on donor screening products.
The QA Scientist will perform testing on raw materials.
This person will assure compliance with company standards and applicable regulatory agencies.
They will participate in failure investigations to help determine root cause, track and trend data, identify and suggest process improvements to improve business measures.
The QC Serologist I will perform testing within established timelines in accordance with current cGMP's.
They will participate in equipment maintenance/calibration program.
The successful candidate will have the ability to prioritize and handle multiple tasks and challenges at one time and can work in a team environment and provide customer focused results in an efficient manner.
The QC Serologist I will document results clearly and accurately as well as be able to interpret results by comparing results against appropriate specification requirements.
They will perform data entry of critical product/process information and test results to be used in trend analysis.
They will maintain work areas and equipment as well as ensure calibration and maintenance of equipment is performed at designated intervals.
The successful candidate will adhere to departmental and Company SOP's and safety requirements as well as be accountable for notifying management of any out of specifications or abnormal trend in results in a timely manner.
They will be accountable for reporting nonconformance's to management immediately.
QA Scientist I will provide support during regulatory audits.
Edits documentation (i.
e.
Standard Operating Procedures, test methods, batch records).
Understands and applies Process Excellence tools in daily work activities.
The QA Scientist I will be familiar with Company safety and environmental policies and perform work tasks and operations in compliance with all safety and environmental rules and regulations, and encourage co-workers to do so; if uncertain, consults with supervisor.
Attend applicable safety and environmental education and training programs and attend departmental safety and environmental meetings.
Immediately report and correct, if possible, unsafe conditions, spills and near miss incidents.
Conduct self-inspections of workstations and offices for hazardous conditions.
All employees are required to cultivate an environment of quality & compliance in their actions.
This includes attending all required training, adhering to the processes & procedures of their role and the company, and displaying the highest level of integrity.
Applicants must provide their phone number.
Reference job number A3838.
QC/ ELISA Scientist (ONSITE) Recommended Skills Auditing Biology Business Process Improvement Calibration Communication Data Entry Estimated Salary: $20 to $28 per hour based on qualifications.
This position is in Raritan, NJ.
This is a day shift position, and you must be able to work between the hours of 6:
30 AM-6:
30 PM (actual shift - 7:
00 a.
m.
- 3:
30 p.
m.
) and have flexibility to work other shifts when necessary.
Weekends and overtime may be required.
Qualifications:
The QC Scientist I will be responsible for testing the stability and final product release of all OCD products.
This person will assure compliance with company standards and applicable regulatory agencies.
They will participate in failure investigations to help determine root cause, track and trend data, and identify and suggest process improvements to improve business measures.
A Bachelor's degree in Medical Technology/Medical Laboratory Scientist, Biology, Chemistry or related field and a minimum of 1-3 years' experience with QC, GMP, GDP, and medical device companies is required.
Experience with ELISA, SDS-PAGE, and electrophoresis.
Familiarity with the guidelines and regulations of FDA, OSHA, and ISO is preferred.
Manual dexterity to handle instruments, complete repetitive motions, and stand for long periods is required.
Diligent use of PPEs (Personal Protective Equipment) to limit exposure to bloodborne pathogens is required.
Excellent oral and written communication skills are required.
Proficiency with the Microsoft Office suite of products (Excel, Word, PowerPoint, Outlook).
Responsibilities:
Organizes and performs product release, stability and raw material testing under direct supervision.
Performs testing within established timelines and in accordance with current specifications.
Documents results clearly and accurately.
Interprets results by complying to appropriate specification requirements.
Perform data trending of critical product, process information and release test results to be used in SPC/ trend analysis.
The QA Scientist I will be responsible for performing release and stability testing on donor screening products.
The QA Scientist will perform testing on raw materials.
This person will assure compliance with company standards and applicable regulatory agencies.
They will participate in failure investigations to help determine root cause, track and trend data, identify and suggest process improvements to improve business measures.
The QC Serologist I will perform testing within established timelines in accordance with current cGMP's.
They will participate in equipment maintenance/calibration program.
The successful candidate will have the ability to prioritize and handle multiple tasks and challenges at one time and can work in a team environment and provide customer focused results in an efficient manner.
The QC Serologist I will document results clearly and accurately as well as be able to interpret results by comparing results against appropriate specification requirements.
They will perform data entry of critical product/process information and test results to be used in trend analysis.
They will maintain work areas and equipment as well as ensure calibration and maintenance of equipment is performed at designated intervals.
The successful candidate will adhere to departmental and Company SOP's and safety requirements as well as be accountable for notifying management of any out of specifications or abnormal trend in results in a timely manner.
They will be accountable for reporting nonconformance's to management immediately.
QA Scientist I will provide support during regulatory audits.
Edits documentation (i.
e.
Standard Operating Procedures, test methods, batch records).
Understands and applies Process Excellence tools in daily work activities.
The QA Scientist I will be familiar with Company safety and environmental policies and perform work tasks and operations in compliance with all safety and environmental rules and regulations, and encourage co-workers to do so; if uncertain, consults with supervisor.
Attend applicable safety and environmental education and training programs and attend departmental safety and environmental meetings.
Immediately report and correct, if possible, unsafe conditions, spills and near miss incidents.
Conduct self-inspections of workstations and offices for hazardous conditions.
All employees are required to cultivate an environment of quality & compliance in their actions.
This includes attending all required training, adhering to the processes & procedures of their role and the company, and displaying the highest level of integrity.
Applicants must provide their phone number.
Reference job number A3838.
QC/ ELISA Scientist (ONSITE) Recommended Skills Auditing Biology Business Process Improvement Calibration Communication Data Entry Estimated Salary: $20 to $28 per hour based on qualifications.
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