Performs a wide variety of QA activities to ensure compliance with applicable regulatory requirements
Assists with GMP internal and external audits.
Assists with training programs.
Performs batch records review.
Perform disposition of product.
Coordinates data and documentation review and analysis.
Processes deviations and non-conformances.
Writes documents, standard operating procedures and reports.
Represents department in cross-functional teams, projects and GXP-related problem resolution.
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.
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.
Regularly lift 10-20 lbs. and occasionally lift up to 50 lbs.
Scope of position:
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