Valeant Pharmaceuticals

Manager, Operations

US-GA-Union City
Job ID
8993
Pos. Category
Operations
Pos. Type
Full Time

Overview

This position will report to the Manufacturing Operations Senior Manager and will be responsible for overseeing the planning and monitoring of manufacturing process activities and working closely with plant personnel to ensure the execution of production activities per the master treatment schedule. 

Responsibilities

  • Supports the Senior Manager in the daily execution of all manufacturing related activities, including but not limited to personnel safety, non-conformance (NC) and CAPA management, schedule adherence, departmental spending, and people management.
  • Works closely with Quality, Facilities, IT, and PE groups to ensure operations are conducted in strict compliance with cGMP guidelines at all times; recommends corrective actions necessary to ensure conformity with quality specifications.
  • Prepares documentation, reports, and standard operating procedures.
  • Provides technical expertise to other departments as part of cross-functional project teams.
  • Supports/leads continuous improvement projects related to compliance, maintenance of business, and/or cost improvement opportunities
  • Oversees the training and development of new employees to ensure all activities are performed with a high degree of efficiency and effectiveness and systems are followed.
  • Supports supervisory team, when necessary, to ensure personnel related matters are addressed consistently and fairly.
  • Supports documentation workflow (i.e. review, comment, approval) via access to all on-site GMP systems, including but not limited to, Kintana, GDMS, and CATSWeb.

 

May be responsible for one or more of the following:

  • Manage a staff of coordinators with a targeted focus on administrative tasks within the department. This includes, but is not limited to: scheduling, capacity planning, process monitoring, logistics, troubleshooting, training, project management, equipment management, exception investigations, and the development and implementation of corrective actions.
  • Provide on-shift supervisory coverage when short-staffed.
  • Change control management and execution, including, but not limited to, documentation (i.e. batch record) changes.

Qualifications

  • Bachelor’s degree in a scientific discipline or equivalent.
  • Typically 7 years related experience in cGMP/FDA regulated industry.
  • Typically 3 years leadership experience.
  • Knowledge of cGMP/ICH/FDA regulations.
  • Proficient in MS Office applications.
  • Strong written and verbal communication skills

 

 

Working Conditions and Physical Requirements:

  • Ability to sit or stand for extended periods of time 
  • Intermittent walking to gain access to work areas
  • Finger dexterity sufficient to use a computer and to complete paperwork activities
  • Vision sufficient to use a computer, to read written materials and to complete paperwork activities;
  • Hearing sufficient to communicate with individuals by telephone and in person
  • Ability to lift up to 25 pounds. Limited exposure to (2ºC - 8ºC); (-20ºC); (-75ºC); (-196ºC) areas.
  • Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10 – 20 lbs and lift up to 50 lbs.
  • May be required to work alternate shifts
  • Ability to gown aseptically for work in Clean Room environments
  • Job performed in a lab, office, or utility (noisy) environment
  • Must have the ability to work around laboratories, manufacturing areas and equipment with exposure to blood, blood products or OPIM (other potentially infectious materials) while donning required personal protective materials.
  • Dendreon is an EEO/AA employer M/F/D/V.

 

 

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