Job Information
ThermoFisher Scientific Sr Administrative Services Coordinator (12-hour days) in Greenville, North Carolina
Work Schedule
12 hr shift/days
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them! Our global organization of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com .
Position Summary:
This individual will be responsible for review of line documentation related to Manufacturing and Filling, conducting technical, quality, and compliance reviews in accordance with current
Good Manufacturing Practices (cGMPs), FDA regulations, and Standard Operating Procedures (SOPs), as well as following up on customer inquiries as they relate to same documentation and compliance issues. This position will review and must have an understanding of the implications of the work and knowledge of the context in which the work is being performed. Position is initial review of documentation for ultimate release for product distribution. This position will be on 12-hour day shift on a 2-2-3 rotation.
Responsibilities/Functions:
Printing and reviewing of documentation related to manufacturing and filling after completion of reconciliation.
Critical review of all above documentation for errors, omissions, overwrites and compliance to cGMPs, customer specifications, and internal SOPs.
Work order status progression from printing to release. This includes high-level communication with inter-departmental support groups.
Perform document reviews and make determinations as to whether work performed meets current procedures and regulatory expectations. Communicate and coordinate with other departments as required to resolve issues and compliance concerns detected during review.
Conduct risk assessments and take appropriate actions during quality oversight activities (e.g. during review/approval) to ensure adequate controls in relation to the level of product quality, safety and business risks.
Provide in-line batch record reviews.
Investigate and respond to external/internal audit findings and customer complaints.
Manage Document Control (Forms, Logbooks, SOPs, and SPLs) for assigned area.
Enter Systems, Applications and Products (SAP) data for batch operations.
Transfer samples to Stability/Retain and transfer samples to Labs using LIMS.
Perform other duties as assigned.
Qualifications:
Education:
High school diploma or equivalent minimally required.
Experience:
Minimum experience required is 2 years of GMP pharmaceutical batch record processing; Four years of relevant experience is preferred
Knowledge, Skills, Abilities :
Outstanding attention to detail and organizational skills.
Self-starter, mature, independent and dependable.
Capable of growing in a fast-paced environment, handling pressure, and multitasking effectively.
Effective time management and prioritization skills.
Requires discretion and great listening skills.
Highly effective verbal and written communication skills.
Physical Requirements:
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch, and sit 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.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.