Senior Manufacturing Formulator - The Fountain Group

The Fountain Group is currently seeking a Senior ­­­­­­­­Manufacturing Formulator for a prominent client of ours. This position is located in ­­Tucson, AZ. Details for the position are as follows:

Job Description:

**ONSITE: Monday-Friday 6am-2:30pm or as scheduled; overtime required**

• The Senior Manufacturing Formulator collaborates to produce reliable medical device products and supplies with effective operations in an empowered organization.
• As part of a dynamic team, the Senior Manufacturing Formulators, responsibilities include performing weigh, mix and in process testing of chemical reagents in a regulated environment, through the manual processing or operation of automated equipment.
• They utilize validated software systems to maintain processes, batch records, and inventory control, ensuring all production related documentation follows quality system regulations.
• Performs in-process testing of reagents as detailed in manufacturing formulas, troubleshoots, and develops standard operating procedures.
• Fulfills reservations by proactively checking open reservations, requesting material, pulling material aliquot and properly labeling material.
• Ensures audit readiness (OSHA, NMPA, FDA, etc.); may be required to represent their team during internal audits/inspections.
• Performs and documents all transactions and production instructions with accuracy related to the proper receipt, quarantine, storage, and disbursement of materials as it relates to FDA, OSHA, QSR, ISO, Good Manufacturing Practices and other company policies and procedures.
• Contributes to the manufacturing schedule by supporting 3 or more reagent product lines (detection, molecular, special stains, antibody, bulk reagents).
• Escalates all quality and production deviations to leadership. Follows through with associated actions and communication.
• Maintains Right to Operate and ensures that all processes are performed in a safe and healthy manner; Addresses and escalates any potentially unsafe hazards; Ensures timely reporting of safety hazards, incidents and near misses using safety reporting tools.
• Associates degree required, bachelors preferred, with industry experience within a laboratory or manufacturing setting (cGMP/GMP preferred) – academic or professional experience handling chemicals or reagents.

Qualifications:

• BS or AS degree
  • May consider recent BS degree
  • AS degree requires extensive GMP Production Laboratory experience
• Wet Bench Techniques
  • required: pipetting, pH, reagent preparation, analytical techniques
• GMP/GDP experience
  • preferred for BS, required for AS
• Production Experience: SOPs, validation, continuous improvement
  • preferred for BS, required for AS
• Biotech/pharma experience
  • highly desired for BS or AS

Compensation: $23-27.50 per hour depending on education & experience