Batch Record Reviewer I

Sharp Services•Conshohocken, PA

3d•Onsite

About The Position

Responsibilities include review of line documentation related to contract packaging. Will follow up on customer inquiries as they relate to same documentation and compliance issue. Complete final review and release for product distribution. The impact of review process directly impacts company compliance to regulatory requirements and customer satisfaction.

Requirements

High School Degree is required.
General knowledge of FDA regulations related to cGMPs required.
General knowledge of cGDPs required.
General knowledge of quality control/assurance required.
Excellent detail skills as they apply to documentation review and compliance required.
Good written and oral communication skills required.
Good organizational and planning skills required.
Excellent interpersonal skills required.
Must be proficient in Microsoft Office Suite, Adobe Acrobat, and QAD.
Ability to apply moderately complex mathematical operations including an understanding of statistical sampling plans and the ability to calculate time, percentages, and decimals.
Basic math skills (addition, subtraction, multiplication and division) are required.
Ability to respond to common inquiries or complaints from customers.
Ability to respond to inquiries from peers and superiors.
Ability to effectively present information to internal groups (Quality Department, Project Managers, New Business Development, Material Management and Operations Department employees) and external groups (customer representatives).
Good reasoning skills for analysis and problem solving are needed.
Over the age of 18.
Will be required to undergo a pre-employment drug test and background check.

Nice To Haves

One to two years related pharmaceutical experience and/or training; or equivalent combination of education and experience is preferred.
Experience in pharmaceutical or related industry is desired.
General knowledge of DEA regulations preferred.
Experience with Pilgrim SmartSolve system desired.

Responsibilities

Responsible for review of documentation related to primary, secondary, and clinical packaging after completion of reconciliation.
Responsible for critical review and logging of all above documentation for errors, omissions, over-writes and compliance to cGMPs, customer specifications, and internal SOP’s.
Responsible for follow-up on all customer inquiries specific to documentation related to the packaging, testing and release of the work in-process or finished product.
Responsible for final release of work in-process or finished product.
Responsible for reviewing and maintaining the QAD Item Master Maintenance and Router Maintenance.
Responsible for logging and maintaining packaging process samples as well as coordinating shipment of samples to customers.
Responsible for maintaining and filing of documentation related to packaging in current appropriate status locations.
Responsible for entering lot specific information into the Quality Dashboard (Access Database).
Responsible for participating in internal, customer, and regulatory audits at the discretion of senior management.
Other responsibilities as required.