Batch Record Review - Ops
Batch Record Review - Ops
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Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
Standard (Mon-Fri)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.) WarehouseJob Description
As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step a step beyond by developing solutions for some of the worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.
Excellent Benefits Package
Review our companys Total Rewards
Medical Dental & Vision benefits-effective Day 1
Paid Time Off & Holidays
401K Company Match up to 6%
Tuition Reimbursement eligible after 90 days!
Employee Referral Bonus
Employee Discount Program
Recognition Program
Charitable Gift Matching
Company Paid Parental Leave
Career Advancement Opportunities
Responsibilities include review of line documentation related to Manufacturing and Filling. Responsible for conducting technical quality and compliance reviews in accordance with current Good Manufacturing Practices (cGMPs) FDA regulations and Standard Operating Procedures (SOPs). Will follow-up on customer inquiries as they relate to 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 to perform the initial review of documentation for ultimate release for product distribution.
Key Responsibilities:
1 - Responsible for printing and reviewing documentation related to manufacturing and filling after completion of reconciliation.
2 - Responsible for critical review of all above documentation for errors omissions overwrites and compliance to cGMPs customer specifications and internal SOPs.
3 - Responsible for work order status progression from printing to release. This includes high-level communication with inter-departmental support groups.
Essential Functions:
- Performs document reviews and makes determinations as to whether work performed meets current procedures and regulatory expectations.
- Communicates and coordinates with other departments as required to resolve issues and compliance concerns detected during review.
- Conducts risk assessments and takes 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.
- Provides in-line batch record reviews.
- Investigates and responds to external/internal audit findings and customer complaints.
- Manages Document Control (Forms Logbooks SOPs and SPLs) for assigned area.
- Enters Systems Applications and Products (SAP) data for batch operations.
Education:
High school diploma or equivalent required.
Experience:
Four years of relevant experience including the pharmaceutical industry and/or documentation review is preferred.
Equivalency:
Equivalent combinations of education training and relevant work experience may be considered.
Competencies:
Outstanding attention to detail and organizational skills. Self-starter mature independent and dependable. Capable of growing in a fast-paced environment handling pressure multi-tasking effectively. Effective time management and prioritization skills. Requires discretion and great listening skills. Highly effective verbal and written communication skills. Familiarity with a variety of concepts practices and procedures.
Employment Type
Full-Time
