SEARCH CAREER OPPORTUNITIES

GENERAL SUMMARY OF POSITION: 

The Manufacturing Compliance Specialist III is responsible to manage and review the development and implementation of equipment and process validation protocols to optimize processes and comply with regulatory requirements.  Manages the creation, revision and control, of departmental Incident/Deviation Reports, Batch Production Records and Standard Operating Procedures. Responsible for the implementation of production and large or small scale manufacturing procedures to optimize processes and meet regulatory requirements. Additionally may serve as a resource for technical issues and problems.

MAJOR RESPONSIBILITIES:

• Manages and writes departmental deviations and incident reports.  Conducts investigation to determine root cause and corrective action. Guides the implementation of corrective actions.
• Schedules and reviews reports on internal, external and QA audit findings and completion of corrective actions.  This includes performing internal audits and escorting QA and the FDA during audits.
• Writes and reviews departmental change controls and planned deviations. This include implementation of these changes through SOP and batch record revision and training.
• Writes and reviews validation protocols and performance qualifications of equipment and/or processes to ensure compliance with cGMP’s and that production schedule requirements are met.
• Writes and reviews batch production records, supporting process records and logs.  Responsible for the timely review and accuracy of all batch records and supporting documentation.
• Manages the creation and maintenance of spreadsheets and databases that are utilized for process and environmental trending.
• Documentation Control: Manages and tracks the development, approval, and training status of SOP’s and Batch Production Records.  Responsible for the continued maintenance of current SOPs according to cGMPs.
• Responsible for the implementation and up-to-date documentation of all training in departmental procedures.
• Writes and reviews departmental environmental excursion reports and reactivation of a controlled area report.  Writes and reviews the implementation of any corrective and preventative actions.
• Assists the Director to coordinate compliance activities during inspections by the FDA.
• Performs additional job related duties as required

REQUIRED QUALIFICATIONS:

• Requires a BS Degree and a minimum of 8 years relevant experience
• Ability to maintain extensive working knowledge and proficiency in applicable cGMP’s and FDA regulations and all current procedures within vaccine and monoclonal antibody manufacturing
• Computer literate and proficient in MS Word, Excel and other relevant electronic systems
• Excellent problem solving skills as well as time management and organizational skills. Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines
• Possesses strong attention to detail, ability to maintain accurate records and excellent proofreading skills
• Must have strong verbal and written communication skills.  Ability to communicate effectively with others internally (up, down, and laterally) and externally to the organization.
• Experience in the following areas is required:
  • Bacterial Vaccines Manufacturing and/or Monoclonal antibody manufacturing
  • Quality Systems
• Experience in the following areas is preferred:
• Occasional travel may be required for the purposes of training and auditing of vendors and CMO’s.
• May require working extended and / or unusual hours to meet business needs