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Quality Assurance Specialist
2 months ago
JOB SUMMARY:
The Quality Assurance (QA) Specialist holds a key position in our Quality & Regulatory Affairs Department supporting QA managers in achieving and maintaining compliance for OTC drug products, medical devices, dietary supplements, and cosmetics. The individual must be data driven/analytical and able to develop and maintain effective working relationship with external suppliers and internal team members.
MAJOR RESPONSIBILITIES/ACTIVITIES:
- Prepare reports by collecting, analyzing, and summarizing regulatory and compliance data and trends such as stability, complaints, nonconformance reports, deviations, investigations, and corrective action preventative action (CAPA).
- Prepare implementation plans and timelines for QA Manager’s approval.
- Support the Good Manufacturing Practices (GMP) audits under the direction of the QA Manager
- Foster close cooperative relationships with all functions in the company relative to quality and GMP compliance.
- Analyze data & propose corrective actions to the QA Manager and to Contractor. These include but are not limited to stability protocols, laboratory methods, master batch records, product specifications, method validations, process/packaging and cleaning validation protocols and reports. Ensures that product dossiers are maintained and kept current.
- Protects organization's competitiveness by keeping information confidential.
- Accomplishes organization goals by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
QUALIFICATIONS:
- BS in a scientific or engineering discipline; previous college internship in a quality department helpful
- Demonstrated sound decision-making process and scientific problem-solving capabilities based on facts, data, and the application of risk management principles.
- Proven track record of working independently and managing multiple responsibilities with a consistent sense of urgency.
- Ability to analyze information.
- Effective verbal and written communication skills and demonstrated interpersonal skills.
- High proficiency in computer skills, Microsoft Office/Project
Travel: 15% ability to travel via car, plane, rail.
LANGUAGE SKILLS:
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
MATHEMATICAL SKILLS:
Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.
REASONING ABILITY:
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
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 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 regularly required to sit. The employee frequently is required to talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, 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.
The noise level in the work environment is usually moderate.
No Sponsorship: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
#HybridWork: We follow a Hybrid work schedule in office Tues/Wed/Thurs (remote on Mon/Fri), but this position must be flexible with business need demands and may be required to work in office Monday and/or Friday (e.g., Audits) .
Salary range: $70k-80k
Work Hours: 40 hours per week.
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