Summary/Objective:
The QA Specialist will be responsible for directly supporting the QA process as assigned by the QA Manager. These activities may include but are not limited to: batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, and other as may come up.
Summary/Objective:
The QA Specialist will be responsible for directly supporting the QA process as assigned by the QA Manager. These activities may include but are not limited to: batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, and other as may come up.
Essential Functions:
Under the direction and supervision of the manager, the QA Specialist will:
- Perform QA review and approval of the following GMP documentation as it relates to the processing equipment and facility to which the position is aligned:
- Batch Records and associated documentation
- Product and Component Release transactions in SAP
- Quality Investigations (Deviations, Product Complaints)
- Standard Operating Procedures
- Completes QA processes including batch record review, product and material disposition and quality issue resolution to maintain the flow of products and documents to meet site objectives
- Stays abreast of evolving regulatory compliance practices
- Reads, understands, and follows SOP’s and aligns with cGMP’s
- Writes new SOPs or revises existing documentation using document management systems
- Supports the evaluation and disposition of labeling, raw materials, intermediates and finished products through timely evaluation of batch records, laboratory results and other cGMP documents
- Supports the issuance and reconciliation of GMP documentation
- Electronic system usage with SAP
- Reviews detailed information from their functional area, reports abnormalities
- Assists by assembling metrics as requested for their functional area.
- Initiates and/or reviews and approves minor deviations; completes tasks related to CAPA and Change Control action items.
- Other duties as assigned.
Required Experience & Skills:
- Bachelor’s degree 2-3 years' experience in the pharmaceutical industry in roles covered by GMP oversight, with QA experience. Excellent oral and written English communication skills.
- Knowledge of Good Manufacturing Practices (GMP)
- Basic Knowledge of pharma/ manufacturing regulations
- Proficiency in MS Word, Outlook, Excel, PowerPoint.
- Proficiency in English usage, spelling, grammar and punctuation.
- Effective planning and organizational skills.
- Requires flexibility and ability to multi-task.
Required Competencies for this Role:
Detailed Oriented
Organized
Reliable
Ability to Multi-task
Flexibility
Self-Starter
Supervisory Responsibility:
None
Work Environment:
While performing the duties the employee is frequently required to sit, stand, walk, and reach with hands and arms; stoop, kneel, crouch or crawl; and see, talk, and hear. The employee must occasionally lift or move up to 20 pounds. Specific vision abilities required by this job include close vision.
Physical Demands:
While performing the duties of this job, the employee is regularly required to use hands and fingers to handle, feel, or operate objects, tools or controls, and reach with hands and arms. The employee is frequently required to stand, talk and hear. The employee might regularly lift and/or move objects up to 50 pounds. No specific vision requirements.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Travel:
NA
Please note that this Job Description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.