• Compliance Manager

    The Ritedose Corporation (Columbia, SC)


    Job Description:

    The Compliance Manager is responsible for managing the Quality Systems for cGMP and impact on product lifecycle.

    Responsibilities:

    + Review product Master Batch Records (MBRs) for completeness and content.

    + Responsible for standardization of master batch record process steps and adherence of new products to applicable standards.

    + Review and approve supporting documents associated with batch production including forms, labeling and specifications for cGMP compliance and accuracy to the product application.

    + Review standard operating procedures (SOPs) and work instructions (WINs). Ensure documents are complete, accurate and compliant with TRC / CFR requirements.

    + Collaborate with the Training department to ensure documents are effectively communicated to TRC employees.

    + Manage Annual Product Reviews and customer complaint program.

    + Manage retain storage and inspections program.

    + Train and mentor Compliance personnel.

    + Support Quality management as directed.

    Qualifications:

    + Four year college degree in Engineering, Pharmacy, Chemistry, Biology or related field

    + Minimum 8 years’ experience in Quality Assurance with focus on cGMP compliance

    + Proven science-based decision making skills

    + Must have knowledge of cGMP guidelines, relevant production processes and QC processes

    + Proficient with current word processing, spreadsheet, and database software

    + Must be detail-oriented and work efficiently

    + Strong interpersonal skills and ability to communicate effectively

    + Ability to manage multiple priorities

    Qualifications

    Qualifications:

    + Four year college degree in Engineering, Pharmacy, Chemistry, Biology or related field

    + Minimum 8 years’ experience in Quality Assurance with focus on cGMP compliance

    + Proven science-based decision making skills

    + Must have knowledge of cGMP guidelines, relevant production processes and QC processes

    + Proficient with current word processing, spreadsheet, and database software

    + Must be detail-oriented and work efficiently

    + Strong interpersonal skills and ability to communicate effectively

    + Ability to manage multiple priorities