Job Description: Position Summary: Senior Formulation role

• Manufactures buffers and simple bulk reagents per manufacturing procedures with limited supervision.

• Participates in process improvemenet projects.

  Key Responsibilities:

• Responsible for reviewing all area documents.

• Responsible for the WNS.

• Assist in manufacture of controls and calibrators and complete batch records following cGMPs.

• Perform in-process assays using equipment such as spectrophotometers, pH meters and clinical analyzers.

• Weighing, transfer, mixing of chemicals required.

• Perform product filtrations.

• Clean and steam steel tanks (CIP) / (SIP).

• Prepare glassware and steel tanks for sterilization in autoclave and operate autoclave.

• Maintain lab equipment including pumps, pH meters, and flow meters.

• Keep department lead or manager updated on all issues.

• Monitor stocks of common lab supplies.

• Performs other job duties as required.

• Responds to Emergency notifications.

• Flexible hours and on weekends.

  Minimum Requirements/Qualifications:

• High school diploma or equivalent. AA degree preferred with at least 2 years of lab experience.

• Basic lab skills and knowledge of safety precautions.

• Familiarity with Quality System Regulations.

• Experienced working with potentially hazardous chemicals and human source materials.

• Must be able to lift 25 lbs routinely.

• May be required to lift up to 50 lbs occasionally.

  Non-Negotiable Hiring Criteria:

• Must be in compliance with GMP, QSRs, ISO and IVD regulations in the performance of department responsibilities.

• Ability to read and write English and understand instructions written or orally in English.

• Ability to add, subtract, multiply and divide in all units of measure, whole numbers, fractions and decimals.

• Knowledge of Word, Excel and Outlook.

  Shift: 8am-5pm M-F OT - 4-8hrs of OT can be expected weekly Duration: 6month contract - looking to convert at end of contract