QA Specialist
QA Specialist
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$ 48000 - 48000
1 Vacancy
Job Description
Job Details
Description
Job Summary
Manage all Quality Assurance activities utilizing the standard operating procedure at Aphena Pharma Solutions TN. Support manufacturing Quality groups mission with specific emphasis on document control & product approval activity
Essential Functions
Ensuring cGMP compliance in all areas of operation with specific emphasis on 21 CFR 210 & 211 (and associated regulatory requirements).
Process and approve all new incoming product submissions and requests for production including submission to the required agencies (FDA CDER DEA CFSAN etc..
Ensure submission and maintaining of all First DataBank Medispan and other nationally recognized price sources (as required) product listings.
Review all change orders or formal deviation requests.
Assure compliance of all SOPs and perform annual internal audits with reports to the Senior
Director of Quality Assurance and Regulatory Affairs.
Coordinate SOP activity including review due dates evaluation development response time and deployment.
Make change notice corrections which affect document control and revision.
Review and approve all master SOPs.
Observe and comply with all company established safety practices.
Participate in and complete all company required training and retraining.
Support manufacturing QC as needed.
Report on and present data to the Quality organization.
Observe and apply organizational policies laws rules and regulation typing accurately making arithmetic calculations and analysis.
Comply with safety regulations and maintain clean and orderly work areas.
Participate in and complete all companyrequired training.
Create and submit all DEA reporting requirements including but not limited to ARCOS YERS
and inventory reports.
Responsible for serving on the QMR Team as well as on the External cGMP Audit Team.
All other duties as assigned
Qualifications
Qualifications
Minimum high school and fouryear S.S. degree or equivalent experience.
Requires extensive knowledge of cGMP standards and procedures.
Experience in developing and managing quality systems.
Must have strong decisionmaking and leadership skills.
Statistical QA analysis.
Proficient in Microsoft Office Suite (Excel Word Outlook)
Ability to communicate in written form and oral presentation.
Supervisory background or experience.
Manufacturing process experience (Production and Quality Control).
Physical / Mental Demands
Frequent sitting typing and use of hands for data entry and document handling.
Frequent viewing of computer screens and printed materials.
Occasional walking standing and reaching for files or office supplies.
Occasional lifting and moving of objects up to 20 pounds.
Frequent mental focus and attention to detail required.
Frequent handling of confidential information with discretion and professionalism.
Frequent communication via phone email and inperson interactions.
Ability to manage multiple tasks prioritize deadlines and adapt to shifting demands.
Required Experience:
Unclear Seniority
Employment Type
Unclear
