Batch Record Reviewer I

About the Role

The impact of the review process directly impacts company compliance to regulatory requirements and customer satisfaction.

Responsibilities

• Review documentation related to primary, secondary, and clinical packaging after completion of reconciliation.
• Perform critical review and logging of all documentation for errors, omissions, over-writes, and compliance to cGMPs, customer specifications, and internal SOPs.
• Follow up on all customer inquiries specific to documentation related to the packaging, testing, and release of work in-process or finished product.
• Final release of work in-process or finished product.
• Review and maintain the QAD Item Master Maintenance and Router Maintenance.
• Log and maintain packaging process samples and coordinate shipment of samples to customers.
• Maintain and file documentation related to packaging in current appropriate status locations.
• Enter lot-specific information into the Quality Dashboard (Access Database).
• Participate in internal, customer, and regulatory audits at the discretion of senior management.
• Perform other responsibilities as required.

Requirements

• High School Degree is required.
• One to two years of related pharmaceutical experience and/or training; or equivalent combination of education and experience is preferred.
• Experience in the pharmaceutical or related industry is desired.
• General knowledge of FDA regulations related to cGMPs required.
• General knowledge of cGDPs required.
• General knowledge of quality control/assurance required.
• General knowledge of DEA regulations preferred.
• 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.
• All employees must be over the age of 18 and will be required to undergo a pre-employment drug test and background check.

Skills

• Mathematical Skills: 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.
• Language Skills: Ability to respond to common inquiries or complaints from customers, peers, and superiors. Ability to effectively present information to internal and external groups.
• Reasoning Ability: Thorough understanding of each aspect of the job is required. Good organizational and reasoning skills for analysis and problem-solving are needed.
• Computer Skills: Must be proficient in Microsoft Office Suite, Adobe Acrobat, and QAD. Experience with Pilgrim SmartSolve system desired.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Regularly required to use hands, speak, and listen.
• Frequently required to sit.
• Occasionally required to stand, walk, and reach with hands and arms.
• Must occasionally lift and/or move up to 20 pounds.
• Specific vision abilities required include close vision, distance vision, and ability to adjust focus.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.