Description
\t\t\t\t\tThis could be a level II or III roleSummary of Position level IIThis position is responsible for performing activities to support analytical testing programs to ensure compliance with cGMP standards including in-process, product release and stability testing. This individual will be required to complete the testing and related documentation in a timely manner while adhering to standard operating procedures and under cGMPs. For level IIIPerforming activities to support analytical testing programs to ensure compliance with cGMP standards including in-process, product release and stability testing. This individual will guide and partner with lower level QC analysts to provide feedback and technical information. This individual will also ensure accurate documentation, timely completion of all analytical related testing, and timely review of data, while adhering to standard operating procedures and cGMPs.Responsibilities and Job Duties:level II•\tPerforms routine analytical testing including more complex methods such as HPLC, CE, ELISA, and Cell Culture as well as basic methods such as concentration by UV absorbance, pH, conductivity, and osmolality, for in-process, product release, and stability samples on a daily basis in accordance with all protocols and procedures. Enters data into Laboratory Information Management System (LIMS).•\tPerforms peer review of test data generated by other analysts as needed to ensure data integrity and adherence to standard operating procedures and GMPs.•\tReports out of specification results from testing to supervisor and assists with performing laboratory investigations to determine the root cause and possible resolution.•\tPerforms routine lab cleaning and equipment maintenance activities in accordance with SOPS as scheduled, and escalates potential equipment issues to supervisor.•\tPrepares general lab solutions and buffers as needed and monitors expirations of these solutions and buffers. •\tIdentifies opportunities for process improvement and makes recommendations to team leader. •\tRevises and updates standard operating procedures, as needed.•\tMay participate in special projects related to problems encountered with testing and instruments, and make recommendations for solutions that will minimize future issues.Level III•\tPerforms routine analytical testing including complex methods such as HPLC, CE, ELISA, and Cell Culture as well as basic methods such as concentration by UV absorbance, pH, conductivity, and osmolality, for in-process, product release, and stability samples on a daily basis in accordance with all protocols and procedures. Enters data into Laboratory Information Management System (LIMS).•\tPerforms peer review of test data generated by other analysts to identify discrepancies and out of range results and to ensure adherence to standard operating procedures and GMPs. Identifies analytical data trends and reports findings and provides recommendation to supervisors for review and consideration. •\tConducts investigation when there are out of specification results from testing and reports to supervisor.•\tInitiates and monitors progress of analytical related Quality event records (e.g., Deviations and CAPAs) and conducts investigations to determine root cause and possible resolution. •\tDevelops, revises, and updates standard operating procedures, as needed.•\tCollaborates with Senior QC team members to participate in the development, transfer, and validation of analytical testing methods and conducts training on analytical test methods to other QC Analysts as needed.•\tOverseas lab equipment calibration and maintenance processes as required for testing per standard operating procedures, and raises any concerns about equipment to supervisor for resolution. •\tParticipates in troubleshooting of analytical test methods and instruments, as needed.•\tPerforms special projects related to problems encountered with analytical testing and instruments, and makes recommendations for solutions that will minimize future issues. •\tMentors and trains lower lever analysts, as needed. •\tPrepares general lab solutions and buffers as needed and monitors expirations of these solutions and buffers.
\t\t\t\t\t\t\t\t\t\tSkills
\t\t\t\t\tQuality control, Gmp, Chemistry, capillary electrophoresis, liquid chromatography, Isoelectric Focusing, Hplc, ELISA, Cell Culture, product release, stability testing, LIMS, gel electrophoresis, UV absorbance
\t\t\t\t\t\t\t\t\t\tTop Skills Details
\t\t\t\t\tQuality control,Gmp,Chemistry,capillary electrophoresis,liquid chromatography,Isoelectric Focusing,Hplc,ELISA,Cell Culture,product release,stability testing,LIMS
\t\t\t\t\t\t\t\t\t\tAdditional Skills & Qualifications
\t\t\t\t\tQualifications level IIEducation & Experience•\tHigh School Diploma and minimum of four years of experience in performing analytical/chemistry testing. •\tAssociate’s degree in a scientific area of study with three years of related experience•\tBachelor’s Degree in a scientific discipline and minimum of two year of direct related experience •\tExperience in one or more of the following areas required: HPLC, CE, ELISA, Cell Culture, Gels, UV absorbance, pH, conductivity, osmolality, Quality Control, and GMP testing.Knowledge, Skills and Abilities•\tStrong knowledge of good laboratory practices.•\tAbility to work independently on assigned methods and follow procedures.•\tAbility to organize and prioritize daily activities to meet internal customer needs in a fast-paced environment.•\tAbility to resolve problems independently and responsively but also know when to raise issues with management. •\tBe able to work in a team environment in a cooperative and respectful manner.•\tAbility to stand for periods of time when performing tasks on the floor.•\tAbility to work a varied schedule including off shift and weekends.•\tAbility to lift up to 50 pounds.Level IIIEducation, Experience, & Credentials•\tHigh School Diploma and minimum of 8 years directly related experience•\tAssociate’s degree in scientific field of study and 5 years of experience•\tBachelor’s Degree in a scientific discipline and minimum of 4 years experience•\tExperience in one or more of the following areas required: Potency testing, Chromatography testing, Quality Control, Raw Material testing, and/or GMP testing.Knowledge, Skills and Abilities•\tWorking knowledge of good laboratory practices. •\tExcellent understanding of GMPs related to the biotech or pharmaceutical industry •\tAbility to organize and prioritize daily activities to meet internal customer needs in a fast-paced environment.•\tAbility to work on extremely complex problems in which analysis of situation or data requires an in-depth
\t\t\t\t\t\t\t\t\t\tExperience Level
\t\t\t\t\tIntermediate Level
\t\t\t\t\tJob Type & LocationThis is a Contract position based out of Rockville, MD.
Pay and BenefitsThe pay range for this position is $34.00 - $44.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace TypeThis is a fully onsite position in Rockville,MD.
Application DeadlineThis position is anticipated to close on Feb 2, 2026.
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