Quality Control AnalystReq I D
This position is focused on service delivery excellence for UnityTM Lab Services. Specific activities relative to the job function could include: Support of Commercial Manufacturing by providing the following services, processing of labware for cleaning and sterilization, Media and Buffer preparation, lab inventory management, Quality Control analysis on manufactured drug product and substance, interpretation of HPLC analysis data, and communication to manufacturing of product Purity, Identity, and Concentration to enable forwards processing of commercial product. This position will utilize intermediate and advanced functionality of systems and applications relevant to the job function. Strong communication skills are also required. The STAT titer portion of this role directly supports commercial manufacturing. During coverage for STAT Titer, Candidate must be able to work variable shifts including second / third shifts, nights, weekends or holidays in order to accommodate the manufacturing schedule.
Job-Specific Duties may include:
Preparation of drug sample product for sample analysis
Use of validated electronic laboratory sample database to create samples, and maintain sample inventory within a LIMS system
Operator level gowning for entrance and work performed in manufacturing suites
Sample preparation of drug product and drug substance
Operation of Waters and Agilent HPLC analysis systems using SEC, IEC, RPC, and Affinity chromatography methods
HPLC Analysis on drug product and drug substance for Purity, Identify, and Concentration (PIC) for STAT and non-STAT samples
Perform first level troubleshooting on HPLC systems, including change out of external and internal components
Interpret HPLC result data for molecule PIC based Method acceptance criteria
Independent data verification of HPLC analysis product for PIC
Communication with manufacturing management of HPLC analysis results for forward processing of commercial product
Perform Biological Indicator testing on manufacturing samples for microbial growth
At all times, comply with safety guidelines, cGMPs and other applicable regulatory requirements
Ensures that, equipment, materials, processes and procedures comply with cGMP practices and other applicable regulations
Alerts Customer management of quality, compliance, supply and safety risks
Completes required assigned training to permit execution of required tasks
Utilization of Good Documentation Practices in all record keeping
Maintaining metric data for work performed
Perform equipment verifications and calibrations following customer and manufacturer's protocols
Maintain Quality Control reagents within customer validated Consumable Inventory Management System (CIMS), including adding reagents, uploading C of A, determination of chemical equivalents, creating su-inventories, and discarding of items
Strict adherence to customer Standard Operating Procedures and Method protocols
Perform primary trainer responsibility for customer validated Methods and procedures
Promote a safe work environment through various safety initiatives within functional area
Participate in individual or group projects that can include, cost savings analysis, learning groups, writing job training methods, and leading team meetings
Master's Degree OR
Bachelor's Degree & 1 year of Quality experience OR
Associate's degree & 3years of Quality experience OR
High school diploma/GED & 5 years of Quality experience
Evident understanding of intermediate HPLC principals
Demonstrated verbal, written and presentation skills
Displays a high level of confidentiality for both customer and Client.
Must maintain client's Four-I Values
Experience in laboratory setting or services preferred
Proven excellence in customer service skills
Detail oriented, problem solver, promotes team environment
Must possess a strong desire to serve the customer, and the interpersonal skills to deal with various levels of personnel at the customer site.
Must possess strong communication skills and customer focus to deliver excellent customer service including maintaining a professional appearance at all times.
Must possess strong analytical skills to interpret scientific data to ensure customer requirements are met.
Must possess the organizational skills to multi-task and meet changing deadlines as needed.
Must be able to use a computer and possess advanced skills in Microsoft Office suite.
Mandatory: Quality Control Lab Analyst
Desired: Contingent Hourly (CWHR)-TEM.CWHR.A00