Specialist, Planning & Scheduling

MSD • Rahway, NJ

1d • $87,300 - $137,400 • Onsite

About The Position

Our company is currently seeking a Specialist with good compliance skills to work in the GMP Sample Repository within the Analytical Chemistry in Development and Supply organization located at the Rahway, NJ. The group is responsible for providing World Class Supply of clinical API, commercial reference standards and other highly valued company compounds across the internal and external company network. The employee will have responsibility for (under the limited guidance of a more senior staff member): Receiving and processing (label, store, subdivide, and ship) all GMP material for distribution to pre-clinical or clinical studies and commercial reference standards in accordance with the SOP’s, cGMP’s, and federal and regulatory guidelines. Ensuring all required documentation associated with material receipt, subdivision, and shipping are accurately prepared and maintained and all inventory and distribution databases are immediately updated. Ensuring proper documentation and information is provided for material shipments originating from the Repository. 1st line for customer service interactions (e-mail or on-line help). Performing administrator inventory systems (MITS, SAP or equivalent) responsibilities and systems related special projects. Participating in identifying, creating, and executing plans for continuous development and to address compliance gaps.

Requirements

• Experience with material handling (Weigh and Dispense workflows) of pharmaceutical grade powders using balances, VBE’s and isolators
• Experience operating in a GMP environment, specifically documentation, data generation and data reporting.
• Effective computer skills, capable to quickly learn and implement area-specific software/database systems.
• Ability to simultaneously track and manage numerous activities against their individual deadlines and priorities
• Effective interpersonal and communication skills, both verbal and written
• Ability to work effectively with team-members of diverse skill sets and backgrounds
• Ability to lift to 40lbs
• High School Diploma or GED with a minimum of 7 years relevant experience OR Bachelor's degree in science, engineering, business, or related areas of study with minimum of 3 years relevant experience

Nice To Haves

• Ability to prepare Standard Operating Procedures (SOP) and cGXP documents
• Experience with SAP
• Supported continuous improvement project development and execution
• Supported site, divisional audits and/or regulatory inspections

Responsibilities

• Receiving and processing (label, store, subdivide, and ship) all GMP material for distribution to pre-clinical or clinical studies and commercial reference standards in accordance with the SOP’s, cGMP’s, and federal and regulatory guidelines.
• Ensuring all required documentation associated with material receipt, subdivision, and shipping are accurately prepared and maintained and all inventory and distribution databases are immediately updated.
• Ensuring proper documentation and information is provided for material shipments originating from the Repository.
• 1st line for customer service interactions (e-mail or on-line help).
• Performing administrator inventory systems (MITS, SAP or equivalent) responsibilities and systems related special projects.
• Participating in identifying, creating, and executing plans for continuous development and to address compliance gaps.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level