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*1 year contract position with additional opportunity based upon performance and continued business need*
The company: Our client is a global healthcare company. The Company offers health solutions through its prescription medicines, vaccines, biologic therapies and animal health products. It operates through four segments: Pharmaceutical, Animal Health, Healthcare Services and Alliances. The Company's Pharmaceutical segment includes human health pharmaceutical and vaccine products marketed either directly by the Company or through joint ventures. Human health pharmaceutical products consist of therapeutic and preventive agents, generally sold by prescription, for the treatment of human disorders. The Company sells its human health pharmaceutical products primarily to drug wholesalers and retailers, hospitals, government agencies and managed healthcare providers, such as health maintenance organizations, pharmacy benefit managers and other institutions. Vaccine products consist of preventive pediatric, adolescent and adult vaccines, primarily administered at physician offices.
Education requirements (e.g., BS in Chemistry or related science) o BA or BS is expected. BS in Chemistry is preferred. (Scientist)
o Minimum 2yrs, preferably 5yrs in an analytical testing lab.
o Operating in a GMP environment, specifically documentation, data generation and data reporting.
• Lab techniques and skills (e.g., HPLC, moisture analysis (KF), dissolution).
Required: Knowledge of Analytical Laboratory Instrumentation and general operation of equipment. o Specific experience with HPLC, GC, chiral LC, SFC, FTIR, balances and compendial wet chemistry techniques.
Specific experience with Empower III CDS.
Other skills needed (e.g., computer, oral / written communication, organizational skills) o Computer skills: MS Office, MS Word, MS Excel. o Superior time management skills required. o Ability to simultaneously track and manage numerous in progress activities against their individual deadlines. o Excellent organization skills. Details oriented. o Good written (scientific) and verbal communication skills.
Responsible for reference standard, annual qualification testing, routine process analysis support, method validation & routine troubleshooting.
ist of activities and responsibilities associated with the role
o Responsible for generating analytical data in support of reference standard qualification / expiry extension using documented test methods.
o Performs laboratory work accurately and on a timely basis. Informs supervisor of any testing abnormalities from expected results. Be able to investigate and troubleshoot unexpected results under minor supervision.
o Responsible for proper recording and review of test results, related data and necessary calculations in a manner consistent with current GMPs and SOPs.
o Responsible for author testing protocols, analytical reports, and certificates of analysis.
o Conducts thorough review and preparation for testing protocols to ensure accurate and most updated version.
o Prepares report memo and protocol appendix as required
o Responsible for identifying testing abnormalities, assessing data trends, troubleshooting analytical testing issues and escalating events to supervisor when appropriate.
o Responsible for method validation & routine troubleshooting
List of additional activities to support reference standard program management
o Review and process ordering request. Communicate with customers if quantity cannot be met.
o Maintain and update internal excel file to record request for a specific vendor. Follow and foresee the usage and provide ordering request to vendor.
o Assist and coordinate with relevant parties to receive RS shipment from vendors and process into database system. Excellent organization skills are required.
o Monitoring and ordering lab supplies and chemicals as needed
o Assist and coordinate routine equipment maintenance
Pay Rate: $30.00 per hour
Drug and background screenings required
On-Board Services provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.
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