SUMMARY:                                                                                                                       

This position is responsible for performing production batch record oversight of GMP compounding activities at SCA Pharmaceuticals. This position performs the production review of batch records and procedures, coordinates testing of samples with the QC department, reviews and evaluate QC data, and evaluates technical change control documents and process validation to ensure that lots meet applicable cGMP requirements prior to release.

The individual is expected to be capable of working with minimal supervision. The Production Batch Record Review Specialist is expected to communicate well with fellow Production Batch Record Review; Quality Assurance; Compounding Operations; Quality Control, Supply Chain and Regulatory Affairs. A self-starter who is capable of identifying, defining and implementing project goals is preferred, and skills to develop task management systems are crucial.

ESSENTIAL FUNCTIONS:

• Review executed compounding batch records, and associated documentation for compliance with cGMPs and consistency with other SCA policies and procedures.
• Coordinates with QC for the testing of samples from compounding
• Review and evaluate QC data for release and approval of batch records and drug product.
• Represents SCA QA during meetings and/or conference calls with clients.
• Coordinate with key Quality and Manufacturing personnel at the site to maintain cGMPs for drug product production, including secondary packaging.
• Evaluate site technical change control documents (TCCs), process deviations and investigation reports prior to management approval to ensure that lots meet applicable cGMP requirements prior to release
• Compiling data required for lot release activities and coordinating with Operations and Customer Support manager to establish lot release schedules.
• Assisting in the development of SCA SOPs, Batch Records and review checklists for compliance with cGMPs and consistency with other SCA policies and procedures
• Perform inspection of drug product rejects/complaint investigation samples as part of QA investigations

SUCCESSFUL CANDIDATES WILL:

• Must have effective communication and interpersonal skills across all functions within the organization and outside.
• Strong organizational and record keeping skills are required.
• MS Word, Excel, and PowerPoint experience is necessary.

SUPERVISORY RESPONSIBILITIES

• • This position will not have any supervisory responsibility.

WORK ENVIRONMENT

• • This job operates in a production/manufacturing environment. Proper protective equipment is worn at all times.

PHYSICAL DEMANDS

• Must be able to lift, push, pull and carry up to 40+ pounds.
• Must be able to sit or stand for 4+ hours at a time as needed.

QUALIFICATIONS:

• High school graduate or GED.

SCA Pharmaceuticals is an equal opportunity employer (Minorities/Females/Disabled/Veterans). We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.