QC Specialist I - 14993726
San Diego, CA 92127
Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.
Title: QC Specialist I
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration: 1+ year contract
- Pay rate: $30-35/hr
- Job Location: San Diego, CA
- Job#: bh13931
QC Specialist I
In order to set expectations and to the extent permitted by applicable law, please note that if an applicant is hired for this position, the applicant will be required to prove that the applicant has been fully vaccinated against COVID-19 by the date of hire, subject to any qualified religious or medical exemptions. Please note that the employer reserves its rights to mandate additional vaccine requirements at any time.
- QC Specialist I is expert in one or more specific job areas to lead testing and release of multiple product lines.
- Responsible for all analytical assay method training to coordinate and perform critical material qualification, date extension justification, material trend analysis and/or other projects that are in addition to typical release, qualification and/or stability testing.
- To provide expertise to their designated QC group, and to accurately assess the purity, potency, efficacy, and other performance characteristics for the purpose of supporting both manufacturing and quality assurance in the production, release, and monitoring of established product lines.
- QC Analytical testing for release of Raw Materials, sub-assembly material product, and final product
- Execute Date Extension Protocol Testing, write routine date extension reports
- Execute thoughtful investigations utilizing detailed root cause analysis and write cogent technical nonconformance investigations
- Perform product trending and write up evidence of trending and complete product trend investigations in the event of a trend alert.
- Execute thorough lab investigations using root cause analysis and determine proper retest instructions.
- Responsible for the QC coordination and communication supporting at least one technical area in QC.
- Responsible for executing experimentation and writing reports to justify QC process, method, and/or specification changes.
- Responsible for managing the day to day release responsibilities of at least two product lines.
- Train new QC employees in a specific area of expertise.
General Laboratory Responsibilities:
- Maintenance and cleanliness of QC equipment, ensuring equipment is within calibration, submitting items for calibration as needed
- Maintenance and cleanliness of the laboratory, stocking shelves/drawers with testing materials
- Completing training in a timely manner and maintaining the records.
- Comply with Site Environmental Health & Safety (EH&S) requirements
- At least 6 years of experience in a regulated GMP testing laboratory with increasing level of responsibility over time
- Must have substantial experience in the areas listed:
- Analytical Test Methods using HPLC, Mass Spectroscopy, Ion Chromatography, and quantitative PCR.
- Assay trouble shooting experience in their expert area.
- Root Cause Analysis, Failure mode investigation execution and writing.
- Pharmacoepeial (compendial) test methods for Raw Materials, color and appearance, identity by FTIR, heavy metals, residual solvents, chloride, sulphate, insoluble matter
- May occasionally lift, carry, push, pull or otherwise manipulate objects up to 25 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight frequently or continuously.
- NOTE: Notification of Hep A&B Vaccines required.
- Bachelor’s degree in Biochemistry, Molecular Biology, Immunology, or Microbiology with 6-8 years or MS degree in science with at least 5 years of experience.
- ANALYTICAL TEST
- ANALYTICAL TEST METHODS
- MASS SPECTROSCOPY
- ANALYTICAL TESTING
- ENVIRONMENTAL HEALTH
- MOLECULAR BIOLOGY
- QUALITY ASSURANCE
- ROOT CAUSE ANALYSIS
- STABILITY TESTING
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