QA Specialist I- Document Review

POSITION SUMMARY

The Quality Specialist I job function is responsible for performing quality assurance tasks and activities with minimal guidance and supervision. The emphasis for this position will be on document review, product labeling and data entry. The Quality Specialist I role will help support the implementation, coordination, and maintenance of Ortec’s Quality Systems.

ESSENTIAL FUNCTIONS

Review documents and forms according to good documentation practices (GDocP) for accuracy, clarity, and completeness; generate/revise documents as needed following change control process Support product release through preparation and review of production and laboratory documentation for accuracy, data integrity, traceability and GDocP (raw materials, intermediates and final goods), review of COA/COC and material labels Prepare product documentation for customer review and approval when required Maintain nonconforming/disposal records Provide support in product/process issue investigations where necessary, e.g. CAPAs, customer complaints Maintain data entry to help support routine reporting of metrics for trending Supports special projects as assigned Support audit readiness with an understanding of FDA (21 CFR 210/211 and 21 CFR 820) and ISO (9001:2015 and 13485) regulations and requirements Maintain a safe, clean, and organized environment (5S) for all QA areas Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices Any additional functions as assigned by the QA Management Sustain and uphold Ortec’s Guiding Principles in all day to day actions

EDUCATION

High School Graduate with 2+ years related experience working in a cGMP quality assurance or manufacturing related environment Bachelor’s degree in Business, English, or Science related field, preferred

EXPERIENCE

Minimum 1-2 years’ experience in a regulated manufacturing environment. Prefer chemical, pharmaceutical or medical device with quality assurance responsibilities specifically in document review

SKILLS & ABILITIES

Basic computer skills: Microsoft Outlook, Excel and Word Ability to multi-task and prioritize responsibilities Excellent organizational skills and attention to detail Excellent written and verbal communication skills Strong interpersonal skills, ability to be flexible and work well as a team player

WORK ENVIRONMENT

Temperature-controlled, carpeted, well-lighted office area; occasional forays into batch chemical manufacturing/lab/warehouse areas

BENEFITS

Medical, Dental, and Vision Insurance Company Paid Short-Term Disability, Long-Term Disability, and AD&D Annual Anniversary Cash Award Quarterly Perfect Attendance Bonus On-Site Nurse Company Paid Employee Assistance Plan 401k with match And much more…

EEO & PRE‑EMPLOYMENT SCREENING

Ortec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identity, national origin, veteran or disability. May be subject to pre-employment screening that may include drug screening, physical, reference checks, employment verifications, and background screenings. #J-18808-Ljbffr Ortec-Inc