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QC Analytical Chemistry Associate - Cook Pharmica

Company Name:
Cook Medical
QC Analytical Chemistry Associate - Cook Pharmica
Job Title: QC Analytical Chemistry Associate - Cook Pharmica
Job Type: Full-Time
Location: Bloomington, IN
Minimum Experience Required: 02
Job Description:
Cook Pharmica is a biopharmaceutical contract development and manufacturing organization (CDMO) with process development, clinical and commercial bulk drug substance manufacturing, formulation development, clinical and commercial parenteral drug product manufacturing, including liquid and lyophilized vials, prefilled syringes and secondary packaging, and an array of support services all at a single facility in Bloomington, IN. Founded in 2004, Cook Pharmica is a division of Cook Medical, the world''s largest privately held medical manufacturing company.
Primary Function
To provide quality control testing of raw materials according to SOPs, cGMPs and regulatory guidelines.
Essential Job Functions/Duties
o Perform and review analytical chemistry testing during phases of production that include incoming raw material ID and release testing
o Provide technical peer review of analytical testing data
o Write/revise technical documents including laboratory procedures, protocols and technical reports
o Independently utilize sophisticated analytical instrumentation such as HPLC, GC, UV, ICP-MS, FTIR, TOC
o Perform biochemical analyses using methodologies such as SDS-PAGE, western blotting, IEF, ELISA, ELLA, mammalian cell culture, IP, CE
o Act as department lead on projects and laboratory investigations
o Recognize atypical/out of specification (OOS) results and perform investigation to determine root cause and implement corrective and preventive actions (investigations are to be completed within 30 days of initiation)
o Develop and execute validation and transfer protocols for new methodology
o Accurately complete necessary documentation
o Interpret and apply US and EU regulations as they apply to the analytical laboratory and production facility
o Perform training on laboratory methods and instrumentation
o Maintain laboratory records and primary data in accordance with applicable regulations and company policy
o Utilize computerized systems such as LIMS and CDS for generating/compiling data
o Follow all established laboratory, regulatory, safety, and environmental procedures
o Calibrate, operate and maintain a variety of lab instrumentation
o Adhere to the standards of quality ruled by current GMP and the compan
Minimum Work Experience/Educational Requirements
o Strong written and verbal communication skills to effectively communicate with co-workers as well as management
o Excellent attention to detail
o Ability to work independently
o Strong analytical and investigative skills
o Strong work ethic, dedication to safety and the desire to be part of a team
o BS/BA in analytical chemistry, life sciences or related field is required, or equivalent work experience
o 2-4 years experience in analytical chemistry or the biotechnology/biopharmaceutical industry is desired
o Ability to work weekends and off-shift hours as needed to support manufacturing activities
o Computer proficiency is required
Physical Requirements/Work Environment
o Majority of day spent on feet in the analytical chemistry laboratory
o Personal protective equipment including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required in most areas associated with this position
o Use of hazardous chemicals on a regular basis
o Must be able to lift/push/pull up to 30 pounds on a consistent basis
We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.

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