Job DescriptionSenior Quality Data Reviewer
- Title: Senior Quality Data Reviewer
- Location: Clearwater, FL
- Industry: Pharmaceutical (GMP environment)
- Pay Rate: $25 an hr.
- Employment Type: 2-month contract (Covering someone on medical leave)
Client Overview A dynamic pharmaceutical technology company that empowers its employees with responsibility and offers a supportive and highly progressive work environment. This company is a contractor development manufacturing organization environment that is fast-paced and mainly focuses on oral solid dosage. Position Overview: The Senior Data Reviewer is responsible for the systems and personnel that oversee the generation of data supporting the client s products. This includes review of laboratory data, equipment records, facility records and manufacturing batch records. Responsibilities:
- Workflow management with multiple reviewers.
- Team leadership of the data review team.
- Approval of analytical method and equipment validation reports.
- Perform final release of product.
- Approval of Certificates of Analysis
- Ensuring data integrity across the company systems
- Adherence to all company procedures
- Auditing documentation including but not limited to batch records, reports, and certificates
- Performing and participating in audits, cycle audits, vendor audits.
- Support of the document control systems.
- Reply to client s questions and inquiries concerning batch record review
- Combining Lab Data with the appropriate Executed Batch Record
- Review of Laboratory Data
- Metrics - (errors by analyst, review category, batch record review etc, provide to specialist)
- Review OOS Investigations
- Submitting Supply Requests to Document Control
- Metrology Review & Approve Calibrations
- Equipment Change Control Approvals
- Review and Approve Cleaning Verification/Validations
- Review Process Validation
- Approval of USP Water System Checks
- Review/Approve/Reject Drug Product Specifications
- Audit Preparation for Health Authority Inspections/Customer Audits as requested
- Other tasks as needed
Qualifications:
- BS in chemistry or closely related discipline
- MS in chemistry or closely related discipline may substitute for work experience
- 5+ years quality department experience in a GMP regulated industry
- 1-2 years in a pharmaceutical quality control laboratory
- Experience with HPLC, spectrophotometers and other laboratory equipment
- Fluency in written English
- Proficiency in MS Office Applications; Outlook, Word, & Excel
- Strong organizational skills
- Proofreading skills
- 30 words per minute typing minimum
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