27 QA Specialist - I Jobs in Frederick, MD
ARTECH is Hiring a QA Specialist - I Near Frederick, MD
Location: Frederick, MD
Duration: 06 Months
Shift - Shift is Sunday – Wednesday 7:00 am- 5:30 pmJob Responsibilities
- Provide QA support on the floor for production
- Ensure process control measures are in place and followed in product manufacturing
- Receipt and disposition of incoming apheresis material.
- Oversee and authorize shipment of final product
- Verify and ensure timely issuance of production documents and labels
- Review batch-related documentation and ensure resolution of issues to release and ship product.
- Gather and report metrics to measure performance
- Identify continuous improvement actions
- Ensure timely resolution and escalation of issues
- Ensure all product-related Deviations are initiated, investigated and resolved.
- Ensure that associated CAPAs are initiated and resolved, as needed.
- Perform lot closure activities.
- Ensure approval and timely delivery of final product.
- Ensure products are manufactured in compliance with regulatory and GMP guidelines.
- Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.
- Perform other duties as assigned
- BA/BS in a technical discipline and experience in Quality Assurance or GMP environment (Drug Substance or Drug Product) OR
- Associates in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 2 years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product) OR
- High School diploma and 5 years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product).
- BS/BA 2 yrs. experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.
- Working knowledge and ability to apply GMPs in conformance to U.S., EU, and ROW standards
- Ability to effectively negotiate and build collaboration amongst individuals
- Strong teamwork and collaborative skills
- Experience with manufacturing investigations, deviations, and CAPA.
- General knowledge of aseptic manufacturing processes.
- Proficient in MS Word, Excel, Power Point and other applications.
- Strong interpersonal, verbal and written communication skills
- Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities
- Willingness to think outside of the box and adapt best practices to a small, but growing environment
- Must be able to work on multiple assignments in collaborative and dynamic environment and demonstrate organizational, prioritization, and time management proficiencies
- Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
Job Summary
Temporary
Business Services
$62k-77k (estimate)
09/12/2024
10/10/2024
artech.com
READING, PA
3,000 - 7,500
1998
Private
JEFFREY LEWIS
$500M - $1B
Business Services
Related Companies
About ARTECH
Artech provides staff augmentation, program management, ERP and workforce and staffing solution.
The job skills required for QA Specialist - I include Quality Assurance, Written Communication, Continuous Improvement, Chemistry, Collaboration, Time Management, etc. Having related job skills and expertise will give you an advantage when applying to be a QA Specialist - I. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by QA Specialist - I. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for QA Specialist - I positions, which can be used as a reference in future career path planning. As a QA Specialist - I, it can be promoted into senior positions as a Quality Assurance Specialist III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary QA Specialist - I. You can explore the career advancement for a QA Specialist - I below and select your interested title to get hiring information.
If you are interested in becoming a QA Specialist, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a QA Specialist for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
Quotes from people on QA Specialist job description and responsibilities
Primarily, their job responsibilities includes evaluating adequacy of quality assurance standards.
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They devise sampling procedures and directions for recording and reporting quality data.
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Plan, conduct, and supervise test and inspection of materials and products to ensure quality is maintained.
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Analyze data to identify areas for improvement in the quality system.
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Develop, recommend, and monitor corrective and preventive actions.
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Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on QA Specialist jobs
Quality assurance specialists ensure production processes follow established regulations and quality standard.
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Quality assurance specialists need to outline quality assurance policies and procedures, making sure that quality standards are assured.
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Every QA team follows a process to have a bug tracking tool like Jira, bugzilla.
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Know how to ask the right questions, and when to ask them.
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Assure ongoing compliance with quality and industry regulatory requirements.
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Step 3: View the best colleges and universities for QA Specialist.
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