Kilo Chemist

Veranova L PDevens, MA
Onsite

About The Position

Under the direction of a Production Supervisor, the Kilo Chemist works on manufacturing Active Pharmaceutical Ingredients (APIs) in support of the business unit while meeting local, state, and federal quality and safety regulations. This role is 100% on site at our Devens, MA facility and will work a rotating shift schedule on all shifts.

Requirements

  • BS in Chemistry, Engineering or other related technical field or High School Diploma with 5-7 years of experience in an API manufacturing facility
  • Must be open to working a rotating 1st, 2nd, and 3rd shifts
  • While performing the duties of this job it is required to stand, walk, and use hands to operate objects, tools, or controls; reach with hands or arms; climb, balance, stoop, kneel, or crouch when necessary for job activity.
  • Able to lift 50lbs and occasionally lift and or/move more than 100 pounds using available material handling equipment.

Responsibilities

  • Completes batch records in accordance with FDA and Current Good Manufacturing Practices (cGMP) guidelines; Maintain the facility in excellent FDA/cGMP position.
  • Demonstrates technical proficiency and self-assuredness in applying cGMP standards; Provide process support and troubleshooting necessary to meet all customer requirements; Ensures a level of housekeeping appropriate for a pharmaceutical manufacturer and maintain 5S areas.
  • Responsible for safety equipment and active participation in safety program and hazard analysis. Wears appropriate PPE for task; Ensures the security and safe handling of all controlled substances at all times. Strictly adheres to all Company and DEA regulations.
  • Ensures that waste is appropriately characterized, labelled, stored, and disposed in compliance with all Company, state and federal regulations. Works collaboratively with Environmental, Health & Safety, as appropriate.
  • Assures all production/support equipment is in proper operating condition and that all production equipment is appropriately documented with current status. Works collaboratively with Maintenance, as appropriate; Active member of Emergency Response Team. Participate in Emergency Response Training and related activities.
  • Cooperate with all root cause investigations and follow corrective actions and compliance with Company policies and procedures, and all state and federal regulations occurs within department; Responsible for contributing to audit readiness and for participating in EH&S audits with internal Company groups, regulatory agencies, and customers; Responsible for reporting all near misses, accidents, and dangerous occurrences through the appropriate Company procedures to ensure an investigation is initiated.
  • Effectively communicates with QC Testing group regarding timing and prioritization of in-process sample requirements.
  • Operates machines and equipment that involves set up and making adjustments to regulate temperature, pressure, flow and reactions or materials safely and in accordance with batch record and work instructions.

Benefits

  • Comprehensive health & wellness benefits.
  • Access to mental health resources and wellness programs.
  • Generous PTO and holiday pay policies.
  • Eligibility for performance-based bonuses.
  • Attractive 401(k) Plan with company match.
  • Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship.
  • Tuition Assistance for Undergraduate and Graduate degree programs.
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