Quality Documentation Coordinator / QA Document Control Specialist at Amerit Consulting Quality Documentation Coordinator / QA Document Control Specialist at Amerit Consulting in Neshanic Station, New Jersey Posted in about 5 hours ago.
Type:
full-time
Job Description:
OVERVIEW
About the job:
- NO Visa Sponsorship/ No H1Bs/ No C2Cs
- 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 Documentation Coordinator / QA Document Control Specialist
- JOB #: 3554
JOB TITLE
Quality Documentation Coordinator / QA Document Control Specialist
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JOB LOCATION
Onsite Role at 50 Country Line Road Branchburg
NJ 08876
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JOB DURATION
Duration:
2-month contract (possible extension)
Pay Rate:
$30.00/hr. - $35.00/hr.
MUST HAVE
Ability to manage competing priorities in a fast-paced environment Good written and verbal communication skills and interpersonal relationship skills Knowledge and understanding of global regulations relevant to medical devices (Class II and/or Class III)
ISO 11607
Medical Device Design Control Packaging Engineering Protocols writing Scientific Technical Writing
POSITION SUMMARY
We are seeking a detail-oriented Quality Documentation Coordinator to support Quality Assurance operations in a GMP-regulated environment. This role is responsible for document control, records management, audit coordination, electronic quality documentation, and administrative support for the Quality department. The ideal candidate has experience working in pharmaceutical, medical device, biotechnology, or laboratory environments with knowledge of GMP documentation, document control processes, and quality systems.
RESPONSIBILITIES
Records Management & Document Control Perform Quality Assurance (QA) review of GMP documentation. Verify ALCOA data integrity requirements and confirm test results meet specifications. Issue controlled forms in accordance with document control procedures. Maintain document check-in/check-out logs. Track project folders and in-process records. Coordinate offsite archival of quality records. Scan and upload quality documents into electronic document management systems. Process Electronic Change Record Orders (ECROs). Maintain accurate document control records . Audit & Meeting Support Schedule internal, client, and regulatory audits. Coordinate facility meetings and site visits. Prepare audit rooms and meeting materials. Support audits through document retrieval and logistics. Coordinate catering and meeting arrangements. Assist auditors and internal teams during inspections. Facilities & Administrative Support Process purchase orders for Quality department supplies. Manage laboratory coat inventory and dry-cleaning coordination. Maintain tracking logs for supplies and site services. Support general Quality department administrative activities .
JOB REQUIREMENTS
Education :
Associate degree or higher preferred in: Business Administration, Life Sciences, Healthcare Administration, Related field OR High School Diploma/GED with relevant experience. 1-5 years of administrative experience Experience in regulated industries such as: Pharmaceutical, Medical Device, Biotechnology, Clinical Laboratory, Combination Products. Familiarity with GMP, GLP, or
ISO 13485
documentation practices is an asset. Prior experience with document management systems or electronic quality management systems (eQMS) is a plus. Proficiency in Microsoft Office Suite (Word, Excel, Outlook); comfort with electronic document management platforms.
Recruiter Contact Info Lalit Malgotra :
lalit.malgotra@ameritconsulting.com www.ameritconsulting.com I'd love to talk to you if you think this position is right up your alley, and assure prompt communication, whichever direction. If you're looking for rewarding employment and a company that puts its employees first, we'd like to work with you.
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.
