Sr Administrative Services Coordinator 12-hour days
Sr Administrative Services Coordinator 12-hour days
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
12 hr shift/daysEnvironmental 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 100000 colleagues delivers an outstanding combination of innovative technologies purchasing convenience and pharmaceutical services through our industryleading brands including Thermo Scientific Applied Biosystems Invitrogen Fisher Scientific Unity Lab Services and Patheon. For more information please visitwww.thermofisher.
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 12hour day shift on a 223 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 highlevel communication with interdepartmental 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 inline 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.
Selfstarter mature independent and dependable.
Capable of growing in a fastpaced 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 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.
Required Experience:
Senior IC
Employment Type
Full-Time
