SUMMARY: 

The Quality Assurance (QA) Compliance Specialist I is responsible for maintaining Quality databases and providing an on-the-floor QA presence and oversight to manufacturing operations.  This position’s role will include identifying compliance risks in the operation prior to and during execution, avoiding deviation whenever possible as well as managing immediate corrective action such that a) adherence to cGMPs and internal procedures/policies are maintained, and b) appropriate immediate corrective action is implemented and effectively documented in order to provide traceability and substantiation of any claims to be made in the investigation. This position primarily works in the cGMP production areas to manage adherence to the quality system and to initiate and assist in the initiation and resolution of deviations.

ESSENTIAL DUTIES, RESPONSIBILITIES AND ACCOUNTABILITIES:

• Maintain environmental monitoring database and compile trend reports
• Maintain Quality databases including Archival and scanning of cGMP documents and records, Departures, media fill programs, and training files
• Perform real-time batch record review to ensure the executed record may be delivered to Quality Assurance, 100% completed and ready for review
• Represent Curia Quality Assurance when managing issues that require immediate corrective action.  Ensure such action taken is appropriate and correctly documented
• Solicit feedback from Manufacturing for operational improvement. Liaison with Process Engineering to ensure that Manufacturing feedback is incorporated, where appropriate, into the process design
• Author or revise SOPs
• Perform manufacturing area and labeling clearances as well as inspection of material
• Review and approve CAPAs, Deviations, Change Controls, Equipment Excursion Reports
• Assist in performing investigations
• Perform internal audits and weekly walkthroughs
• Perform QA visual inspection activities associated with clinical and commercial drug product
• With supervision, may respond or manage responses to clients regarding manufacturing and/or documentation issues
• Assist in developing and delivering training
• Assist in tracking and follow-up on Deviations, Change Controls, Investigations, and CAPAs
• Develop and/or maintain Quality System metrics for management review

EDUCATION AND EXPERIENCE:

Required

·         Associates’ degree in related field required

Preferred

·         Bachelors’ degree in life science field

·         3-5 years’ experience in a  cGMP FDA-regulated industry

OTHER REQUIREMENTS:

·         Strong familiarity with the regulatory requirements of 21CFR210 and 211 or 820

• Excellent written/oral communication skills
• Focused self-starter with attention to details; team-oriented but able to work independently and proactively, and ability to multi-task
• Strong problem solving and organizational skills
• Experience working in a cleanroom with a thorough understanding of cleanroom personnel and material flows a must

While performing the duties of this job, the employee has the potential of being exposed to fumes or airborne particles and toxic or caustic chemicals (wearing proper Personal Protective Equipment will be required in these situations).  The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; and may be expected to work with electronic equipment (always being aware of one’s environment and taking proper precautions is required).  The noise level in the work environment is usually moderate.

Employee may be responsible for moving and/or generating hazardous waste for treatment, storage and disposal. Affected employee will need to be familiar with the applicable training requirements included in the customized Resources, Conservation and Recovery Act. Employee will understand waste labeling, secondary containment, chemical compatibility, storage time limits, container size and quantity limits, container integrity when waste is left unattended and improper disposal of hazardous materials.