Job Description

OVERVIEW:

Our client, a US Fortune 250 company and a global medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an accomplished Quality Assurance & Documentation Specialist.

*** JOB TITLE: Quality Assurance & Documentation Specialist

*** LOCATION: Onsite Work || Client location - 99 Hayden Ave., Lexington, MA 02421

*** DURATION: 6 Months

Must haves :

• Inventory management software experience (JDE, Oracle) would be great
• Familiarity with calibration
• How to read calibration

Responsibilities:

• Responsible for ensuring that all raw materials and products batch records are reviewed and released in a timely manner and in compliance with all Quality requirements. Assist in Calibration, Environmental Monitoring Reviews and Preventive Maintenance Administrator. The Quality Specialist will support the Quality Systems such as: Audits, CAPA and Management Review.
• Duties involve using different procedures, requiring the use of judgment and analysis of facts to determine action to be taken within the limits of established acceptance standards. Additionally, it requires a sense of urgency regarding matter of serving the customer and compliance needs.
• Performs independent review of textile raw materials and subassemblies including yarns, fabrics, and tubular fabrics for conformance to specifications, including calculation of results using formulas and Excel spreadsheets. Ensures that all product lots meet the established in-process procedures, specifications and inspections, before his/her approval to release.
• Ensures that completed lot history records submitted for lot release review are secured prior to disposition. Responsible for timely completion of final product shipping authorization documentation.
• Maintain and file the lot history records and release activities documentation.
• Conducts Data and documentation review and analysis.
• Maintains receiving inspection, work in process and finished product DHR records, procedures, and specifications. Review lot history folders for final lot release sign off and files them in the appropriate location.
• Review a database with all yarn and chemical re-test dates required by the specification.
• Assist in writing inspection and test procedures and other documents relevant to incoming/receiving inspection, work in process, finished product and Lot Release.
• Assists coordination of calibrations. Maintains calibration log and coordinate calibration of the respective gauges and equipment.
• Assist in the environmental monitoring reviews.
• Support the Quality Systems such as: Audits, CAPA and preparation of the Management Review deck.
• Assist Quality Manager/Quality Engineer in data collection, review, analysis and reports as necessary (related to re-works, sorting, lot release, inspection process time studies etc.).
• Reviews device history records and associated documentation in preparation for lot release to shipping, maintains lot release records with high degree of legibility, accuracy, neatness and organization.
• Follow established company rules and regulations, safety precautions, and maintain quality standards.
• Regular attendance and punctuality.
• Assist in maintaining supplier quality database. Perform data entry and generate monthly supplier history reports.
• Perform reviews and inspections of new and existing products as needed.
• Assist Quality Engineer by providing input for test procedures and test protocols.
• Maintain neat and accurate records for all testing performed.
• Computerize and analyze results of studies using software packages such as Windows, Excel, Word and Statistical analysis software.
• Perform other related duties as assigned.

Required Qualifications:

• Education: Associate’s degree in sciences or related discipline or High School diploma and minimum 4 years of relevant Quality experience required
• Two or more years of experience working in a medical device or other regulated industry
• Must have ability to read, write, interpret, comprehend, and consistently follow specifications written in English
• Must have strong attention to detail
• Ability to manage multiple priorities and tasks in a dynamic environment
• Ability to work in a team environment
• Computer literacy particularly with databases and spreadsheets / basic ability to use Microsoft Office required
• Good oral and written communication skills. Ability to coordinate work cross functionally.
• Basic understanding of Good Manufacturing Practices (GMP) and Quality System Regulations (QSR)

I'd love to talk to you if you think this position is right up your alley, and assure a prompt communication, whichever direction. If you are looking for rewarding employment and a company that puts its employees first, we'd like to work with you.

Recruiter Name: Lalit Malgotra

Title: Lead Recruiter

Phone: 925-297-6323

Company Overview:

Amerit Consulting is an extremely fast-growing staffing and consulting firm. Amerit Consulting was founded in 2002 to provide consulting, temporary staffing, direct hire, and payrolling services to Fortune 500 companies nationally: as well as small to mid-sized organizations on a local & regional level. Currently, Amerit has over 2,000 employees in 47 states. We develop and implement solutions that help our clients operate more efficiently, deliver greater customer satisfaction, and see a positive impact on their bottom line. We create value by bringing together the right people to achieve results. Our clients and employees say they choose to work with Amerit because of how we work with them - with service that exceeds their expectations and a personal commitment to their success. Our deep expertise in human capital management has fueled our expansion into direct hire placements, temporary staffing, contract placements, and additional staffing and consulting services that propel our clients’ businesses forward.

Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without 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.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Applicants, with criminal histories, are considered in a manner that is consistent with local, state and federal laws

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