Job Description

Our large pharmaceutical client is seeking a Laboratory Report Specialist to join their growing team in Spring House, PA (hybrid schedule). The Report Specialist will provide writing and data analytics support to the Bioanalytical Discovery and Development Sciences Department within R&D in a fully electronic global database (RIMDocs) system for writing, reviewing, and finalizing all bioanalytical reports, technical reports, qualification summary reports and method validation reports. This role will work independently to assist scientists, scientific leaders, and external partners to pull data from multiple systems and then write and format reports according to the submission standards. Primary responsibilities include: Navigate reports through electronic workflows for scientific/compliance reviews, electronic signatures, and regulatory submission preparation; Assist in creating submission ready templates; Apply relevant internal standards, regulatory, and publishing guidelines to submission, internal reporting, external reporting, and documentation. This role has a hybrid schedule that requires this individual to be onsite 3 days a week in Spring House, PA. Other responsibilities include:

• Pulling and analyzing data from LIMS and RIMDOCS to create reports and documentation for the Bioanalytical Discovery & Development teams
• Work hand in hand with scientific teams to revise and prepare method validation and technical reports, document templates and regulatory submissions
• Ensures the appropriate formatting of internal and external documents such as Bioanalytical Reports, technical reports, and validation reports as directed by supervisor, the medical writers and other clinical or research personnel.
• Draft bioanalytical reports and ensures documents are produced in accordance with procedures, guidelines, and electronic templates
• Navigate documents through the review and approval workflows.
• Ensures quality and accuracy of documents through proofreading and application of correct formatting and performing grammar/spell checks.
• Works with analysts and within data repositories (i.e., LIMs, OpenLab, ELN, etc.) to create appropriate content.
• Assists in training of Bioanalytical Discovery and Development Sciences Department staff on appropriate use of reporting systems and electronic templates.

Qualifications:

• Bachelor’s Degree in Biology, Biological Sciences, or a related field of study
• 2+ years of GMP Laboratory Report writing experience
• Prior experience with drafting validation reports is highly preferred
• Experience with LIMS and/or ELN systems

Salary: $75,000-$95,000 (flexible based on experience)

Hours: Monday-Friday, 8:00am-5:00pm

Schedule: 3 days onsite & 2 days remote per week

Hiring Method: Multiyear contract – After 1 year on contract, the individual will have the opportunity to apply for a permanent role or have their contract renewed for another year

PTO: 10 PTO days, 6 paid sick days annually & paid Holidays

Benefits: Medical, Dental, Vision and 401K plans available

Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

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