Primary Objective of Position
The QA Associate III will be responsible for a product line(s) as assigned by the manager. This includes responsibility for the release of materials in accordance with cGMPs and Standard Operating Procedures, review of validation documents, change controls, procedures and other documents related to their assigned product line(s). The QA Associate III is responsible for monitoring various activities and evaluating trends.
• Independently review and release materials associated with their product line(s) or with other product line(s) when needed as back-up. Prepare and/or approve Certificate of Analysis and Certificate of Conformance (55%)
• Review stability data and experimental/engineering/validation protocols. (15%)
• Review deviations and investigations for acceptability. Participate in performing investigations in conjunction with Manufacturing, Packaging, and/or Quality Control as necessary. (10%)
• Review and approve or write procedures. (5%)
• Assist in monitoring of the packaging and manufacturing areas on second shift and as needed for special projects. QA Associate III may be required to monitor reworks, reprocesses or monitor or execute special testing such as inspections. (5%)
• Monitor and evaluate logs of laboratory investigations, deviations, non-conformances and other information as deemed necessary. Investigate trends, prepare reports and notify management of issues needing further review. (5%)
• Lead meetings including writing agendas and minutes (5%)
• Act as back-up to the QA Associate Director prioritizing and assigning work as necessary.
• Attend scheduling meetings when necessary
• Conduct or assist in training of QA Associates
Minimum Job Qualifications
B.S/B.A in appropriate science/industry related field supplemented with additional work experience.
Minimum six years experience in Quality Control, Quality Assurance or pharmaceutical manufacturing. Experienced in current Good Manufacturing Practices and familiar with simple statistics such as 3 sigma control limits, standard deviation, etc. Two years experience in writing technical reports and/or investigations.
Licenses, Certificates, Registrations
• Strong analytical skills, with an ability to use scientific knowledge and statistical methods to identify potential problems and trends.
• Ability to organize and write scientific reports
• Good project management skills
• Strong computer skills and knowledge of word processing software and spreadsheet software
• Competent in leading meetings, investigations and team projects
• Competent in pharmaceutical compliance and regulatory policies
• Knowledge of pharmaceutical industry guidelines, trends and practices
• Act with professionalism and treat others with respect and consideration regardless of their status or position
• Ability to gather information from multiple sources and coordinate and analyze their impact on each other.
• cGMP training
Physical and Mental Demands and Work Environment
The physical and mental demands and work environment described her are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
While performing the duties of this job, the employee is regularly required to use hands to finger, handle, feel or operate objects, tools or controls; and reach with hands and arms. The employee is frequently required to stand and talk or hear; walk or sit; balance, stoop, kneel, crouch or crawl.
The employee is occasionally required to push, pull and lift various pieces of equipment. The employee must occasionally lift and/or move up to 50 pounds (drums).
Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.
While performing the duties of this job, the employee is regularly required to use English written and oral communication skills; interact appropriately with staff, management contractors, vendors and others encountered in the course of work; read and interpret a variety of documents and instructions furnished in written, oral, diagram, or schedule form such as safety rules, operating and maintenance instructions, and procedure manuals; collate and interpret technical and engineering data; generate technical reports; analyze and solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists; establish priorities and work on multiple assignments and projects concurrently.
The employee is regularly required to apply computer skills covering word processing, spreadsheet and presentation software. The employee is regularly required to apply mathematical formulae.
The employee works under typical office conditions. The noise level in the work environment is usually quiet to moderate.
Special Working Conditions
Travel - 5-20% based on experience – for training and assistance in auditing.
FLSA Status: Non-Exempt