Are you interested in GMP legislation and QA?
Function
The Review Specialist position is responsible for handling pre-manufacturing reviews, post-manufacturing reviews and GMP administration. During review assignment, this position will ensure products are processed according to customer requirements before product release. During administration assignments, the position will coordinate document handling needed for compliance with ISO 13485, as well as daily operations in the GMP Manufacturing department
Responsibilities
- Main focus willbeonGMP review:
- Completes preliminary reviews of entered orders and specifications
- Makes independent decisions regarding a product's path based on individual attributes of the product and customer requirements
- Performs final manufacturing reviews: Identifies and investigates inconsistencies between requested specifications and final oligo specifications
- Reviews and documents procedures used for each product in custom software or by other controlled methods
- Makes pass/fail determinations based on QC testing and customer requirements
- Adheres to customer specifics (in a strict manner) as well as general work instructions and SOPs
- Troubleshoots and corrects inconsistencies and problems that may occur during daily operations
- Investigates customer complaints and obtains data for customer inquiries when necessary
- Assists in utilizing metrics to monitor and communicate TAT and error rate to lab and upper management
- Collaborates with members of team, as well as management, to ensure open communication and teamwork
- Additionally,GMP administration tasks can be performed:
- Identifies effectively, the need for documentation/process changes, process deviations, product non-conformances and other occurrences that can indicate the ineffectiveness of quality and/or manufacturing systems
- Creates work instructions, standard operating procedures (SOP) and oligo master records (OMR) that meet customer requirements
- Reviews current documents, proofreads others' new documents for accuracy, and makes necessary changes.
- Performs training on new procedures
- Performs controlled copy and internal reference document audits
- Coordinates audit preparedness activities
- Maintains GMP Mfg's websites (group and department SharePoint sites, CCM TechReview, etc).
- Initiates PCOs when necessary for process and instrument changes
- Participates in the validation of processes performed in the group
- Collaborate closely with QA department
Profile
Education:
- Degree in science related field plus 2 years of applicable lab experience preferred, or equivalent work experience
Experience:
- Proficiency in a variety of PC software programs with strong working knowledge of Microsoft Office (and an emphasis on Excel) required
Skills:
- Proficiency with Excel, PowerPivot, JMP, or other statistical analysis software preferred
- Proficiency with Word and PowerPoint preferred
- Ability to fluctuate priorities throughout the workday required
Offer
- Perm position in a growing, international company!
