Vacancy expired!
Fast Growing Pharmaceutical Company looking to hire a Quality Assurance Associate immediately
This is a permanent full time position with great benefits and room to grow!
SCOPE OF POSITION
Responsibilities of the Quality Assurance Associate (Batch Release) include managing the manufacturing, compounding, and fill batch record review and release, investigate discrepancies, review In-process material records, and Assist in maintaining records for the Quality Assurance Group. Ensure Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP). Support and preparation of documentation for customer and regulatory audits.
PRIMARY RESPONSIBILITIES
Reviews production batch records and associated data for product release. Determines if records are within range of cGMP regulations. Reviews data obtained for compliance specifications and report abnormalities.
Supports most quality functions and potential issues.
Assists in the writing of detailed reports and analyzes quality data.
Creates, revises, and reviews SOPs including compliance documentation initiation, revisions, and deletions. Ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems.
Ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems.
Creates cGMP labels and reviews and reconciles cGMP label generation.
Manage change control program, and training program. Assign number and file Change Control package.
Issue, file, and distribute all company-controlled documents. Update SOP manuals and table of content index for each SOP manual.
Ensure all controlled documents revision and effective date are expedited accordingly.
Maintain all official manufacturing documentation, quality control documentation, 510K packages, and validation packages.
Issue batch lot numbers for various drug and medical device products.
Review, release, and reconcile printed materials (labels and unit carton) for accuracy.
Print official copies of the documents to record current data as a request of the departments.
Check printed material for new product artwork.
Check Printed Material Inspection Sheet and attach Printed Material Inventory Sheet.
Update documentation database as needed.
Responsibilities are not limited to the content mention above
REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES
Complies and adheres to existing and new regulations.
Complies with all company policies and procedures.
Must be a team player and customer / results oriented.
Comply with all company safety policies and procedures to ensure a safe and healthy environment.
Able to have flexible time and overtime (OT) to support manufacturing.
QUALIFICATIONS
Pharmaceutical experience is highly desired and will be given precedence.
Proficient in Microsoft Excel, Microsoft Word, Microsoft Dynamics GP and File Maker Pro for data management.
MINIMUM REQUIREMENTS
Bachelors degree (BS) preferred.
Preference: Normally receives no instruction on routine work and general instructions on new assignments. Strong verbal communication, proficient in technical writing, and excellent interpersonal skills are required.
Interested and qualified candidates please submit your resume to be considered immediately
Vacancy expired!