Specialist, Planning & Scheduling
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Job Description 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. Education Minimum Requirement: 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 Required Experience and Skills: 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 Desired Experience and Skills: 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 #MSJR Required Skills: Adaptability, Clinical Supplies Management, Clinical Supply Chain Management, Consumer Relations, Continuous Development, Cross-Functional Communications, Customer Service Management, Database Management Systems (DBMS), Data Management, Detail-Oriented, GMP Compliance, GMP Environments, GxPs, Improvement Projects, Interpersonal Communication, Inventory Control Management, Logistics Coordination, Production Planning, Proper Documentation, Standard Operating Procedure (SOP), Supply Chain Metrics Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $87,300.00 - $137,400.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic locati
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