QC Analyst II; Swing Shift *PC

This position is primarily responsible for coordinating and conducting day-to-day Quality Control activities for in-process and final product release testing including GMP release testing and execution of Quality Control Method Development with minimal to no supervision. This role may also be responsible for performing all GMP activities to support client and internal company projects while following applicable SOPs with precision and accuracy and demonstrating a high level of documentation accuracy and clarity.

Essential Duties and Responsibilities:

• Facilitate, coordinate, and conduct tasks (i.e. setting schedules to ensure timely completion of of QC test methods including flow cytometry analysis, Nucleic Acid Extraction, qPCR, ELISA, under supervision.
• Execute QC release, in-process and stability testing of raw materials, in-process and final products with flexible schedule. Strictly follows test procedures and SOPs.
• Support and participates in development of QC methods and procedures.
• Responsible for the accuracy and validity of testing results.
• Maintain accurate and complete records per cGMP. Supports assay optimization and qualification.
• Partner and collaborate with Quality to address QC assay issues.
• Support assay execution and training in areas where qualified.
• May assist with equipment qualification and validation activities.
• May support other functional areas or duties as necessary or assigned.

Requirements:

• Bachelor’s degree in the life sciences or related from a four-year college or university with a minimum of 2 years relevant experience and/or training in a laboratory or cGMP/cGTP environment (clinical, microbiology, hematology, immunology or Quality Control).
• Working knowledge of quality systems, including but not limited to change controls, deviations, CAPA's, GxP regulations and standards. Knowledge and experience with laboratory techniques including flow cytometry, qPCR, ELISA and Cell-based assays. Preferred.
• Demonstrated ability to effectively communicate with cross functional groups.
• Experienced and knowledgeable in laboratory techniques including pH, Osmolality, qPCR, ELISA and Cell-based assays.
• Experienced with MS Office (Word, Excel and PowerPoint).

Skills:

• Proficient in QC test methods/procedures and use of the QC lab equipment.
• Proficient in Flow Cytometry, qPCR, ELISA, and cell-based assays.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel;

reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a clean laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, pipettes and computers.

While performing the duties of this job, the employee is exposed to viruses and bacteria. Employees entering the laboratory must wear appropriate clothing and protective equipment such as lab coats, glasses and gloves. The noise level in the work environment is usually moderate.

The hiring range for this position is expected to fall between $34.71-$37.77/hour, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications.

The salary of the finalist(s) selected for this role will be set based…