Administrative Services Coordinator II Batch Reviewer - 12 hour nights
Administrative Services Coordinator II Batch Reviewer - 12 hour nights
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Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
12 hr shift/nightsEnvironmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety StandardsJob Description
Position Summary:This role involves reviewing line documentation related to Manufacturing and Filling. The individual will conduct technical quality and compliance reviews inline with current Good Manufacturing Practices (cGMPs) FDA regulations and Standard Operating Procedures (SOPs). This position requires an understanding of the works implications and the context in which it is performed. The role involves the initial review of documentation for the ultimate release of product distribution.
Key Responsibilities:
Review documentation in realtime during production and after batch reconciliation. Perform critical reviews of all documentation for errors omissions overwrites and compliance with cGMPs customer specifications and internal SOPs. Typical work hours are 6p 6a on a 223 rotation. This role will need to go into the aseptic core which is a cleanroom environment and head to toe sterile gowning will be required.
Functions:
Conduct document reviews and determine if work performed meets current procedures and regulatory expectations.
Communicate and coordinate with other departments to resolve issues and compliance concerns identified during reviews.
Provide inline batch record reviews.
Enter data into Systems Applications and Products (SAP) for batch operations.
Other duties as assigned.
How will you get here
Education:
High school diploma or equivalent minimally required.
Experience:
Up to two years of relevant/transferrable experience.
Knowledge Skills Abilities:
Outstanding attention to detail and interpersonal skills.
Selfstarter mature independent and reliable.
Ability to work in a fastpaced environment under pressure while multitasking.
Effective time management and prioritization skills.
Requires discretion and excellent listening skills.
Highly effective verbal and written communication skills.
Familiar with a variety of concepts practices and procedures.
Familiar with Microsoft word and excel.
Physical Requirements:
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand walk stoop kneel crouch periodically for prolonged periods of time; manipulation (lift carry move) of light to medium weights of 1035 pounds; arm hand and finger dexterity including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard computer monitor operate equipment and read materials for prolonged periods of time; ability to sit reach with hands and arms talk and hear for prolonged periods of time.
Our Mission is to enable our customers to make the world healthier cleaner and safer. As one global team of 100000 colleagues we share a common set of values Integrity Intensity Innovation and Involvement working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need.
Required Experience:
IC
Employment Type
Full-Time
