Reference #: 1757563
Advantage Technical is seeking a QC Coordinator (Chemistry)
for our client in Allentown, PA! This is a 6-months contract-to-hire position, a quick start and money in your pocket!Pay: $24-$26 per hour
Shift:12:30PM - 9PM / M-F + $1 differential = $27.26/hr
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.ExpectationsQuality 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:
Performs routine product analysis and testing (Chemistry Lab - pH, specific gravity, acid/base titration, viscosity.
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].
Conducts Out of Specification [OOS] product testing investigations, experiments, studies, and tests related.
Assists Laboratory Supervisor/SMEs in performing instrument operation, troubleshooting, calibration and instrument maintenance, as necessary.
Reviews and interpret analytical data generated in the lab.
Adheres to cGMP, cleanroom-controlled environments requirements and SOPs.
Other tasks may be assigned as deemed necessary by the Laboratory Supervisor/SMEs.
Experience/Training/Education/Etc.
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.
Ability to follow work instructions and SOPs to perform tasks.
Knowledge of Good Documentation and Laboratory Practices
Detail oriented with strong written and verbal communication skills.
Ability to work under the guidance and supervision of Laboratory Supervisor/SMEs and be able to assist QC Laboratory Technicians with routine testing tasks.
Must be familiar with Microsoft Office applications. Knowledge & Skill Requirements:
Good analytical, writing, interpersonal, and organizational skills
Ability to meet deadlines
Effective communication skills
Must be detail oriented and have multi-tasking capabilities with ability to prioritize.
Physical Demands:
Some travel may be required. Ability to stand and/or sit for long periods of time.
Ability to reach, grasps, stoop, pull and perform repetitive motion procedures.
Ability to lift, push or pull up to 40 lbs. Work Environment: 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:
Perform and review the Daily Compliance Verification
Checklist, document results, and report to immediate supervisor.
Perform and/or coordinate completion of:
Environmental monitoring documentation e.g.
personnel monitoring, air bioburden, surface bioburden, temperatures and
article counts.
Collect Environmental Monitoring samples as
necessary.
New staff training.
Sterility tests, aseptic technique
qualifications, and media fill process validations.
Perform Document review of anticipatory and as
appropriate non-sterile to sterile compounding batch records:
Verify that raw materials meet specification
limits.
Verify accuracy of labeling.
Perform final disposition of Batch.
Verify that product test results meet
specification limits.
Verify that all documentation is complete.
Document non-compliance and evaluate if further investigation
is needed.
Submit samples to the appropriate labs for
chemical assay and microbial tests.
Track vendor equipment calibration and
maintenance records and assess for deviations.
Enter test results or summaries into the
pharmacy specific monthly and quarterly Quality Assurance report template.
Under the direction of supervisor, document
results of deviation and complaint investigations, casual analysis, corrective
actions and preventive actions.
Support internal and external audits.
Maintain quality records (equipment calibration
and maintenance, training, deviation and complaint investigation, environmental
monitoring, Certificate of Analysis, clean room certification, etc.)
Participate in Director of Pharmacy's staff
meetings
Expertise: Knowledge & Skills
Knowledge of pharmacy operations and regulatory
guidelines
Ability to perform pharmacy calculations.
Education:
Bachelor's Degree Required. Bachelor's of
Science preferred.
Minimum of 2 years experience in a QC/QC
department of a pharmaceutical or Allied Health Science.
Desired:
Minimum of 2 years experience in pharmacy
preparation.
Pharmacy Technician Certification.
After you have applied, download our Staffmark Group WorkNOW App to receive real-time job offers and apply for additional opportunities. You can download it from the App Store or get it on Google Play. About Advantage Technical
With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit .
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