WorkSmart Staffing
http://www.worksmartstaffing.com
http://www.worksmartstaffing.com
true
Quality Assurance Data Reviewer
1301 Perimeter Road Greenville, SC 29605 US
Posted: 05/02/2024
2024-05-02
2024-06-16
Employment Type:
Contract To Hire
Job Category: manufacturing
Job Number: 11832
Job Description
SUMMARY
Quality Assurance Data Reviewer assists in maintaining quality systems as they pertain to current industry, regulatory and customer requirements for FDA and ISO 13485 standards. Also assists the QA Supervisor in maintaining the established systems.
ESSENTIAL DUTIES AND RESPONSIBILITIES
QUALIFICATIONS
Pharmaceutical or manufacturing experience preferred.
EDUCATION AND EXPERIENCE:
Associate’s degree in Pharmaceutical, medical or related field is preferred.
Minimum education requirements include a high school diploma or equivalent. Individuals with experience in a cGMP environment with effective communication and reasoning skills are preferred.
LANGUAGE SKILLS:
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to effectively present information and respond to questions. Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.
MATHEMATICAL SKILLS:
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
REASONING ABILITY:
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
COMPUTER SKILLS:
To perform this job successfully, an individual should have knowledge of Database software; Design software and Word Processing software.
PHYSICAL DEMANDS
The physical demands described here 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 the essential function.
While performing the duties of this job, the employee is frequently required to sit. The employee is occasionally required to walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to fumes or airborne particles. The noise level in the work environment is minimal.
PERSONAL PROTECTIVE EQUIPMENT
Lab coat, safety glasses with side shields, protective gloves.
WorkSmart is an Equal Employment Opportunity Employer. We prohibit discrimination and harassment with regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
In order to be considered for employment, applicants must have authorization to work in the United States.
Our company maintains a zero-tolerance policy for illegal drug use or possession in the workplace. Pre-employment drug screening may be conducted, and employees may be subject to random testing.
Quality Assurance Data Reviewer assists in maintaining quality systems as they pertain to current industry, regulatory and customer requirements for FDA and ISO 13485 standards. Also assists the QA Supervisor in maintaining the established systems.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Assists in review of batch records and corresponding documentation prior to product disposition.
- Distributes and tracks controlled copies of packaging batch records (PBR) for production.
- Assists and manage in establishing Policies and Procedures
- Assists in routine maintenance of P&Ps, including periodic reviews
- Reviews shipping documents prior to all shipments of product.
- Issues deviation report (DEV), out of specification (OOS), Corrective Action / Preventative Action (CAPA) s and change control (CC) numbers.
- Assists in preparation for customer visits prior to audits and collecting documents during audits for review by the auditor or investigator.
- Reviews QC analytical results to assure that material meets specifications and releases/rejects as dictated by findings.
- Performs real time on-floor review of PBRs.
- Work with Production and Quality to ensure timely completion of corrections
- Ensures documents are received and filed in a timely manner.
- Performs raw material review and disposition, in addition to maintaining computer system.
- Review and compile records.
- Inspect retains.
- Assists in maintaining compliance status of the facility.
- Effectively communicates with management.
- Cross train as needed for rework/inspection.
QUALIFICATIONS
Pharmaceutical or manufacturing experience preferred.
EDUCATION AND EXPERIENCE:
Associate’s degree in Pharmaceutical, medical or related field is preferred.
Minimum education requirements include a high school diploma or equivalent. Individuals with experience in a cGMP environment with effective communication and reasoning skills are preferred.
LANGUAGE SKILLS:
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to effectively present information and respond to questions. Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.
MATHEMATICAL SKILLS:
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
REASONING ABILITY:
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
COMPUTER SKILLS:
To perform this job successfully, an individual should have knowledge of Database software; Design software and Word Processing software.
PHYSICAL DEMANDS
The physical demands described here 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 the essential function.
While performing the duties of this job, the employee is frequently required to sit. The employee is occasionally required to walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to fumes or airborne particles. The noise level in the work environment is minimal.
PERSONAL PROTECTIVE EQUIPMENT
Lab coat, safety glasses with side shields, protective gloves.
WorkSmart is an Equal Employment Opportunity Employer. We prohibit discrimination and harassment with regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
In order to be considered for employment, applicants must have authorization to work in the United States.
Our company maintains a zero-tolerance policy for illegal drug use or possession in the workplace. Pre-employment drug screening may be conducted, and employees may be subject to random testing.
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