Work Schedule

Environmental Conditions

Job Description

Purpose:

Provides basic level of support, with management oversight, to the QA department in one or more specialized areas or processes to assist in the execution of the Quality Management System (QMS) and company contracted services as required by the functional area(s).

Essential Functions and Other Job Information:

Major Job Responsibilities

• Conducts internal audits or activities in area of expertise, e.g. Facility audits, process audits
• Assists in client and regulatory inspections/audits and follows up on assigned audit issues and corrective action.
• Evaluates acceptability of data based on criteria set forth in SOPs and methods.
• Maintains and updates products and systems associated with global records classification, retention and disposition
• Maintains and updates products and systems associated with global records classification, retention and disposition.
• Utilizes department checklists to evaluate content of reports and compliance with applicable procedures.
• Scans, photo copies, files and ensures that records are kept up-to-date. 
• Participates in inter-departmental meetings and contributes to policy-making decisions.

Job Knowledge

Learns to use professional concepts. Applies company policies and procedures to resolve routine issues.

Job Complexity

Works on problems of limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.

Supervision Received / Freedom to act

 Normally follows established procedures on routine work, requires instructions only    on new assignments.

Interactions / Business Relationships

Contacts are primarily with immediate supervisor, and other personnel in the department. Builds stable working relationships internally.

Qualifications:

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification; Associates' degree and relevant experience is acceptable in lieu of Bachelor's degree.

Previous lab or QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0-2 years).

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, and Abilities:

• Introductory knowledge of applicable GxP and appropriate regional regulations
• Working knowledge of SOPs and WI’s
• Strong oral and written communication skills (including appropriate use of medical and scientific terminology)
• Good attention to detail
• Able to work independently or in a team environment
• Good problem solving skills
• Maturity to handle sensitive and confidential information appropriately
• Good organizational and time management skills
• Basic computer skills; ability to learn and become proficient with appropriate software
• Demonstrated flexibility and adaptability

Management Role:

No management responsibility

Working Conditions and Environment:

• Work is performed in an office with exposure to electrical office equipment.
• Personal protective equipment required such as protective eyewear, garments and gloves when in laboratory spaces
• Travel as required by special projects and supervisor needs. 
• Variable work hours to accommodate schedules

Physical Requirements:

• Ability to work in an upright and /or stationary position for 6-8 hours per day.   
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.  
• Frequent mobility required.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.    
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of up to 50 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others to obtain or relate information to diverse groups.   
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.  Ability to perform under stress.  Ability to multitask.  
• Regular and consistent attendance.

Percent Billable:

60-80%