Administrative Services Coordinator II (Batch Reviewer - 12 hour nights)

Work Schedule

Environmental Conditions

Job Description

Position Summary: This role involves reviewing line documentation related to Manufacturing and Filling. The individual will conduct technical, quality, and compliance reviews in-line with current Good Manufacturing Practices (cGMPs), FDA regulations, and Standard Operating Procedures (SOPs). This position requires an understanding of the work's 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 real-time 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 2-2-3 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 in-line 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.

• Self-starter, mature, independent, and reliable.

• Ability to work in a fast-paced 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 10-35 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 100,000+ 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.

Apply today! http://jobs.thermofisher.com
 
Accessibility/Disability Access: We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.