Quality Assurance Senior Specialist, Compliance

Job Description

Job Description

TITLE

Quality Assurance Sr. Specialist, Compliance

POSITION SUMMARY

This position is responsible for leading non-conformances, client complaints, the CAPAs and

assisting with the auditing program-client, internal and external.

POSITION REPORTS TO:

Quality Assurance Compliance manager or above

POSITION SUPERVISES:

None

ESSENTIAL DUTIES AND RESPONSIBILITIES

The essential functions include, but are not limited to the following:

• Lead the Xerimis, Inc. NCE and CAPA programs

• Review and approve completed NCEs and work with an NCE tracking system to track the

completion and approval of NCEs.

• Review and approve completed CAPA and work with a CAPA tracking system to track the

implementation of approved CAPAs, CAPA follow-ups, and the effectiveness evaluation

of completed CAPAs.

• Route and collect signatures for the approval of NCEs and CAPA.

• Gather metrics for NCEs and CAPAs and to be presented during relevant meetings and

Quality Review Boards.

• Support in various Quality Review Boards

• Support appropriate reports and interact with clients during visits and/or audits.

• Assist with the completion of internal and external audits, as needed

• Review and approve temperature and temperature/humidity charts and review data

logger monitoring documentation, as needed.

• Assist with the maintenance of the Change Control Program

• Enter and verify data in the Inventory Control System (ICS)

• Serve as a backup for various QA and QC functions including release of incoming

materials and shipment of CTM

• Maintain work area in accordance with cGMPs.

• Other duties as assigned.

MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, AND ABILITIES)

• Bachelor’s degree or equivalent work experience

• Excellent interpersonal skills

• Excellent English reading and English writing skills

• Excellent English communication skills

• Excellent problem solving/investigational skills

• Excellent mathematical skills

• English literacy

• Computer literacy skills, including basic knowledge of Microsoft® Word,Excel, PowerPoint

and Visio (preferred)

• Attention to detail

• Effective time management skills

• Strong understanding of GMPs

• Familiarity with the pharmaceutical industry a plus

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to sit. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; and stoop, kneel, crouch, or crawl. The employee may occasionally need to lift and/or move up to 30 pounds. While performing the duties of this job, the employee is exposed to an office environment and occasionally exposed to the warehouse and operations (packaging) environment including occasional exposure to elements such as odor, noise, dust, heat, cold or chemicals. The noise level in the work environment is usually moderate.

Note

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at will” relationship.

The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.