Chemistry Quality Coordinator
Advantage Technical is seeking a QC Coordinator (Chemistry) for our client in Allentown, PA! This is a 6- months contract-to-hire position. Pay:
$24-$26 per hour Shift:
M-F:
6:
00AM-2:
30PM OR 12:
30pm-9pm with $1
differential. Required
Experience:
cGMP experience, Investigation experience, UPLC. Bachelor's degree in a science such as Biology, Microbiology, or Chemistry with a minimum of 1 year of experience in quality or manufacturing department of a Pharmaceutical, Medical Device or any regulated industry. Expectations Quality Control Laboratory Coordinator:
The Quality Control Laboratory Coordinator will perform quantitative and qualitative analysis of compounded products for distribution to customers nationwide. Perform routine laboratory analyses by following written procedures. Preparing and standardizing reagent solutions. Follows instrument and equipment check procedures, troubleshoots when needed, and reports any equipment problem as soon as possible. Abide by all documentation procedures and maintain a level of professionalism throughout each working day. Works with Laboratory Supervisor/SMEs to formulate recommendations for disposition or other actions related to product non 1 conformances, process deviation, product complaints investigations.
Responsibilities:
o Performs routine product analysis and testing (Chemistry Lab - pH, specific gravity, acid/base titration, viscosity. o Perform technical review of test results for completeness and compliance to cGMP's to ensure that excellent documentation following Good Documentation Practices GDP , controls and traceability are in place to maintain data integrity Data Integrity
ALCOA . o Conducts Out of Specification OOS product testing investigations, experiments, studies, and tests related. o Assists Laboratory Supervisor/SMEs in performing instrument operation, troubleshooting, calibration and instrument maintenance, as necessary. o Reviews and interpret analytical data generated in the lab. o Adheres to cGMP, cleanroom-controlled environments requirements and SOPs. o Other tasks may be assigned as deemed necessary by the Laboratory Supervisor/SMEs. Experience/Training/Education/Etc. o Bachelor's degree in a science such as Biology, Microbiology, or Chemistry with a minimum of 1 year of experience in quality or manufacturing department of a Pharmaceutical, Medical Device or any regulated industry. o Ability to follow work instructions and SOPs to perform tasks. o Knowledge of Good Documentation and Laboratory Practices o Detail oriented with strong written and verbal communication skills. o Ability to work under the guidance and supervision of Laboratory Supervisor/SMEs and be able to assist QC Laboratory Technicians with routine testing tasks. o Must be familiar with Microsoft Office applications. Knowledge & Skill Requirements:
o Good analytical, writing, interpersonal, and organizational skills o Ability to meet deadlines o Effective communication skills o Must be detail oriented and have multi-tasking capabilities with ability to prioritize. Physical Demands:
o Some travel may be required. o Ability to stand and/or sit for long periods of time. o Ability to reach, grasps, stoop, pull and perform repetitive motion procedures. o Ability to lift, push or pull up to 40 lbs. Work Environment:
o Indoors, working environment limited to a small area, wearing protective laboratory attire, tolerating controlled temperatures and loud noise.
Summary:
Ensure site-specific compliance with our client's Standard Operating Procedures (SOPs).
Responsibilities:
o Perform and review the Daily Compliance Verification Checklist, document results, and report to immediate supervisor. o Perform and/or coordinate completion of:
o Environmental monitoring documentation e.g. personnel monitoring, air bioburden, surface bioburden, temperatures and particle counts. o Collect Environmental Monitoring samples as necessary. o New staff training. o Sterility tests, aseptic technique qualifications, and media fill process validations. o Perform Document review of anticipatory and as appropriate non-sterile to sterile compounding batch records:
o Verify that raw materials meet specification limits. o Verify accuracy of labeling. o Perform final disposition of Batch. o Verify that product test results meet specification limits. o Verify that all documentation is complete. o Document non-compliance and evaluate if further investigation is needed. o Submit samples to the appropriate labs for chemical assay and microbial tests. o Track vendor equipment calibration and maintenance records and assess for deviations. o Enter test results or summaries into the pharmacy specific monthly and quarterly Quality Assurance report template. o Under the direction of supervisor, document results of deviation and complaint investigations, casual analysis, corrective actions and preventive actions. o Support internal and external audits. o Maintain quality records (equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification, etc.) o Participate in Director of Pharmacy's staff meetings Expertise:
Knowledge & Skills o Knowledge of pharmacy operations and regulatory guidelines o Ability to perform pharmacy calculations. Education:
o Bachelor's Degree Required. Bachelor's of Science preferred. o Minimum of 2 years experience in a QC/QC department of a pharmaceutical or Allied Health Science. Desired:
o Minimum of 2 years experience in pharmacy preparation. o Pharmacy Technician Certification Recommended Skills Biology Calculations Calibration Communication Coordinating Corrective And Preventive Action (Capa) Apply to this job. Think you're the perfect candidate? Apply on company site $(document).ready( function() $(#ads-desktop-placeholder).html(
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n Estimated Salary: $20 to $28 per hour based on qualifications.
$24-$26 per hour Shift:
M-F:
6:
00AM-2:
30PM OR 12:
30pm-9pm with $1
differential. Required
Experience:
cGMP experience, Investigation experience, UPLC. Bachelor's degree in a science such as Biology, Microbiology, or Chemistry with a minimum of 1 year of experience in quality or manufacturing department of a Pharmaceutical, Medical Device or any regulated industry. Expectations Quality Control Laboratory Coordinator:
The Quality Control Laboratory Coordinator will perform quantitative and qualitative analysis of compounded products for distribution to customers nationwide. Perform routine laboratory analyses by following written procedures. Preparing and standardizing reagent solutions. Follows instrument and equipment check procedures, troubleshoots when needed, and reports any equipment problem as soon as possible. Abide by all documentation procedures and maintain a level of professionalism throughout each working day. Works with Laboratory Supervisor/SMEs to formulate recommendations for disposition or other actions related to product non 1 conformances, process deviation, product complaints investigations.
Responsibilities:
o Performs routine product analysis and testing (Chemistry Lab - pH, specific gravity, acid/base titration, viscosity. o Perform technical review of test results for completeness and compliance to cGMP's to ensure that excellent documentation following Good Documentation Practices GDP , controls and traceability are in place to maintain data integrity Data Integrity
ALCOA . o Conducts Out of Specification OOS product testing investigations, experiments, studies, and tests related. o Assists Laboratory Supervisor/SMEs in performing instrument operation, troubleshooting, calibration and instrument maintenance, as necessary. o Reviews and interpret analytical data generated in the lab. o Adheres to cGMP, cleanroom-controlled environments requirements and SOPs. o Other tasks may be assigned as deemed necessary by the Laboratory Supervisor/SMEs. Experience/Training/Education/Etc. o Bachelor's degree in a science such as Biology, Microbiology, or Chemistry with a minimum of 1 year of experience in quality or manufacturing department of a Pharmaceutical, Medical Device or any regulated industry. o Ability to follow work instructions and SOPs to perform tasks. o Knowledge of Good Documentation and Laboratory Practices o Detail oriented with strong written and verbal communication skills. o Ability to work under the guidance and supervision of Laboratory Supervisor/SMEs and be able to assist QC Laboratory Technicians with routine testing tasks. o Must be familiar with Microsoft Office applications. Knowledge & Skill Requirements:
o Good analytical, writing, interpersonal, and organizational skills o Ability to meet deadlines o Effective communication skills o Must be detail oriented and have multi-tasking capabilities with ability to prioritize. Physical Demands:
o Some travel may be required. o Ability to stand and/or sit for long periods of time. o Ability to reach, grasps, stoop, pull and perform repetitive motion procedures. o Ability to lift, push or pull up to 40 lbs. Work Environment:
o Indoors, working environment limited to a small area, wearing protective laboratory attire, tolerating controlled temperatures and loud noise.
Summary:
Ensure site-specific compliance with our client's Standard Operating Procedures (SOPs).
Responsibilities:
o Perform and review the Daily Compliance Verification Checklist, document results, and report to immediate supervisor. o Perform and/or coordinate completion of:
o Environmental monitoring documentation e.g. personnel monitoring, air bioburden, surface bioburden, temperatures and particle counts. o Collect Environmental Monitoring samples as necessary. o New staff training. o Sterility tests, aseptic technique qualifications, and media fill process validations. o Perform Document review of anticipatory and as appropriate non-sterile to sterile compounding batch records:
o Verify that raw materials meet specification limits. o Verify accuracy of labeling. o Perform final disposition of Batch. o Verify that product test results meet specification limits. o Verify that all documentation is complete. o Document non-compliance and evaluate if further investigation is needed. o Submit samples to the appropriate labs for chemical assay and microbial tests. o Track vendor equipment calibration and maintenance records and assess for deviations. o Enter test results or summaries into the pharmacy specific monthly and quarterly Quality Assurance report template. o Under the direction of supervisor, document results of deviation and complaint investigations, casual analysis, corrective actions and preventive actions. o Support internal and external audits. o Maintain quality records (equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification, etc.) o Participate in Director of Pharmacy's staff meetings Expertise:
Knowledge & Skills o Knowledge of pharmacy operations and regulatory guidelines o Ability to perform pharmacy calculations. Education:
o Bachelor's Degree Required. Bachelor's of Science preferred. o Minimum of 2 years experience in a QC/QC department of a pharmaceutical or Allied Health Science. Desired:
o Minimum of 2 years experience in pharmacy preparation. o Pharmacy Technician Certification Recommended Skills Biology Calculations Calibration Communication Coordinating Corrective And Preventive Action (Capa) Apply to this job. Think you're the perfect candidate? Apply on company site $(document).ready( function() $(#ads-desktop-placeholder).html(
n
n
n Estimated Salary: $20 to $28 per hour based on qualifications.
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