Master Associate, Pre-Weigh & Sampling, Supply Chain Services

Duties

The Master Associate in Weigh and Dispense, Raw Material Sampling, and Supply Chain Services is responsible for overseeing and executing weigh, dispense, raw material sampling and warehouse operations related to multi-product bulk drug substance. This role is critical in ensuring the timely supply of materials in support of the production schedule and client demands. The Master Associate will also play a key role in promoting process excellence, adhering to all regulations, and maintaining safety within the warehouse environment.

With adequate training, independently carries out fundamental operations, which include but are not limited to, weighing and dispensing, preparing equipment, assembling kits, staging, raw material sampling and conducting associated warehouse activities. Ensures compliance with manufacturing and Supply Services schedules, maintaining a "Right First Time" approach.

• Sampling of raw materials
• Execute and coordinate Raw Material sampling and delivers sample to Quality Control for testing
• Trains other associates and technicians on methods and processes.
• implements fundamental improvements to lab processes compliance activities
• Adheres strictly to established regulations and site-specific cGMP.
• Accurately and promptly reports any abnormalities and deviations.
• Works collaboratively with the team to establish preventive measures and develop effective solutions to prevent the recurrence of events.
• Keeps production areas maintained according to 5S standards.
• Undertakes internal support duties such as:
  • Restocking consumables and materials
  • Updating controlled SOP binders
  • Properly discarding expired chemicals.
• Provides support to warehouse operations as needed.
• Documents work according to cGMP and cGDP.

• Adheres to established regulations and follows cGMP established by site.
• Reports abnormalities and deviations in a timely and accurate manner.
• Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.
• Maintains production areas according to predefined standards (5s).
• Works with management to ensure readiness for Audit of Agencies and Customers. Following "Audit Ready Standards".
• Maintains own training within compliance.
• Trains other technicians and associates on operations upon completion of trainer qualification.
• Contributes to Quality activities as investigations and area walk-throughs.

• Strong understanding of regulatory requirements such as GMP, FDA, DEA, OSHA, and safety.
• Ensure compliance with all warehouse processes in accordance with these government regulations and company policies, procedures, goals, and objectives.
• Required to work according to given schedules in a 24/7 shift structure and flexibility to adapt working schedule upon prior given notice.
• Proficiency in MRP systems like SAP, BioMES, GoTrack, Lab Ex raw material dispensing, operation of industrial material handling equipment.
• Ability to handle multiple tasks simultaneously and make quick decisions in a fast-paced environment.
• At least 5 years of experience in warehouse, logistics, weigh and dispense, or supply chain, and at least 3 years of GMP experience.
• Some college coursework is a plus.
• Technical skills: proficiency in an MRP system like SAP and BioMES, familiarity with inventory control systems, raw material dispensing experience.
• Strong interpersonal effectiveness and leadership skills to mentor others.
• Must regularly lift and/or move up to 20 pounds, frequently lift and/or move up to 40 pounds, and occasionally lift and/or move up to 60 pounds.
• 5 or more years of experience in cGMP regulated industry preferred.
• Ability to concentrate on detail-oriented work in a complex technical setup with a Quality and Right the first time mindset.
• Strong written and verbal communication skills.
• Ability to work with computer-based systems and ideally experience with process control systems (e.g. SAP) and manufacturing execution systems (MES).
• Ability to read and understand SOPs and work instructions and document work in a written format applying cGMP standards.
• Ability to work as part of a high performing team and collaborate effectively with staff.

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.