of Position Implements and executes validation projects including Equipment Validation, Packaging Validation, Computer System Validation, Data Integrity Assessments, and Cleaning Validation. Coordinates with cross functional resources in the execution of validation projects and ensure compliance with FDA, cGMP, and any other appropriate regulations. Supports manufacturing

of Position Blend defined quantities of designated raw materials (per specific manufacturing instructions) into final dosage blend stage. Executes all Production processes while strictly adhering to cGMP, Standard Operating Procedures, documentation protocols, environmental health and safety guidelines and any other related regulations that could apply. The Blending Techni

of Position Processes active compound materials into final tablet form performing quality control checks to maintain consistency of product according to manufacturing specifications. Executes all Production processes while strictly adhering to cGMP, Standard Operating Procedures, documentation protocols, environmental health and safety guidelines and any other related regu

Occupational Health Coordinator II Overnight Mon Thurs 6 00pm 6 00am Salary Range $44,354.00 $70,967.00 Plus $3.00 Per Hour Shift Differential Responsible for medical support of all aspects of plant, as well as assisting with patient care functions in the Medical Department. Responsible for the scheduling of the OSHA mandated physicals, fitness center memberships, safety

of Position Implement and execute validation projects ranging from New Product Development, Equipment Validation, Process Validation, Packaging Validation and Cleaning Validation. Coordinate with cross functional resources in the execution of validation projects and ensure compliance with FDA, cGMP and any other appropriate regulations. Support manufacturing and packaging

of Position Blend defined quantities of designated raw materials (per specific manufacturing instructions) into final dosage blend stage. Executes all Production processes while strictly adhering to cGMP, Standard Operating Procedures, documentation protocols, environmental health and safety guidelines and any other related regulations that could apply. The Blending Techni

Programming Changes that Repair/Optimize Equipment Performs automation/controls programming in accordance with accepted practices and company standards. Programs HMIs using MS SQL Server, MS Visual Basic and modification of existing Factory Talk View Studio, SE and ME projects. Investigates equipment performance and identifies any problems for corrective actions and solut

Provides Environment, Health and Safety (EHS) functional leadership and management to the Hobart site. Develops and implements a comprehensive EHS Program that is in compliance with Mallinckrodt and regulatory requirements. Acts as a program and project liaison between Mallinckrodt Corporate EHS and the site. Tracks environmental, OSHA and biological safety compliance, mo

Blend defined quantities of designated raw materials (per specific manufacturing instructions) into final dosage blend stage. Executes all production processes while strictly adhering to cGMP, Standard Operating Procedures, documentation protocols, environmental health and safety guidelines and any other related regulations that could apply. The Blending Technician is exp

Responsible for continually monitoring processes and procedures primarily for inventory control of controlled substances active pharmaceutical ingredient (API) and finished dose, preparation of U.S. Drug Enforcement Administration (DEA) controlled substances quota requests and reporting of controlled substances transactions in accordance with state and federal controlled

Works with respective functional group in developing and implementing project scope and cost estimates. Works with respective functional group(s), incorporating business data (sales, financial, etc.) where appropriate, to generate a compelling project justification and application for approval of funds. Works with all internal stakeholders to develop User Requirement Spec

OF POSITION Perform basic quantitative and qualitative analyses of pharmaceutical components, in process material, finished good product, and/or stability product. Depending on the department to which the incumbent reports some of the functions listed may not be applicable. ESSENTIAL FUNCTIONS Perform basic analytical laboratory tests (such as potency, purity, uniformity,

Salary range $46,000.00 $50,000.00 + $3,500.00 Sign On Bonus Samples Tested Perform basic analytical laboratory tests (such as potency, purity, uniformity, dissolution, moisture, etc.) in accordance with approved methodology and cGMP, FDA, and DEA regulations, including a. Set up, adjustment, calibration and operation of laboratory equipment and instruments, as well as an

OCS Level 1 Has familiarity with the listed essential functions and is able to perform/apply at a basic entry level. OCS Level 2 Displays a working knowledge of the listed essential functions and is able to perform/apply at an intermediate level. Takes initiative and lead on minor events, progressing into basic major events, for investigations, RCA, CAPAs, etc... OCS Leve

OF POSITION Perform advanced quantitative and qualitative analyses of pharmaceutical components, in process material, finished good product, and/or stability product. Depending on the department to which the incumbent reports some of the functions listed may not be applicable. ESSENTIAL FUNCTIONS 1. Perform advanced level analytical laboratory tests (such as potency, purit