Kelly Services Documentation Clerk - Part Time in Gurabo, Puerto Rico

Kelly Services is currently seeking a QA Documentation Clerk for one of our top clients in Gurabo, PR

POSITION SUMMARY :

Responsible of maintaining control filing of the Quality Assurance Regulatory Compliance Documentation Area, ensuring the conformance of the current Good Manufacturing Practices, JSC and J&J policies, and internal procedures. Maintains a database for the documentation in the area, provides in a timely manner documentation requested during regulatory/internal inspections, in support of internal investigations and/or studies. Responsible for the proper filling and storage of all documentation delivered to the area such as Manufacturing & Packaging Batch Records, Incoming Area Records, Validation Protocols & Reports, NDAs/DMFs, Annual Product Review, Cleaning log books, and basically all documents related with product disposition and other QA/RC Documentation. Responsible to digitalize all regulatory documentation using AQUARIUS system. Responsible to coordinate the legal services for any affidavit or document that needs official authorization. This position will coordinate departmental meetings, maintains inventory of office supplies, procurement of laboratory supplies as needed, maintain updated department personnel lists to support monthly reconciliation of headcount monitoring of purchases (POs) with suppliers as requested.

RESPONSIBILITIES

  1. Maintains an updated database for all documentation within the Central Documentation Area.

  2. Maintains control of the Regulatory Compliance Central Documentation Area. Assures no records are taken out of the area without proper authorization and control. Responsible to verify the retrieval form.

  3. Files documentation in the Documentation Center, such as Manufacturing & Packaging Batch Records, Raw Material & Packaging Components Records, Validations, Laboratory Data, Reconciliation Forms, NDAs, DMFs, APRs & Others.

  4. Responsible for maintaining/filing updates to NDA/DMF’s. Fill-out form 749 for NDA regulatory correspondence.

  5. Provides support to handle the complaint system in regards to batch record requisitions. Coordination of departmental meetings, maintain inventory of office supplies, procurement of laboratory supplies, maintain updated department personnel lists and negotiate contracts and/or purchases with suppliers as requested.

  6. Responsible to digitalize (AQUARIUS SYSTEM) all regulatory documentation as required.

  7. Responsible to assign and close logbooks (Master Logbooks).

  8. Responsible to log any analytical and microbiology lots from previous and current year.

  9. Provides support during external audits (make copies of documents as requested, stamp & sign documentation, provide documents, keep control of documents that are taken out of the area, print documents requested and others).

  10. Acts as Record Coordinator for the QA/QC/RC Department documentation stored at the Records Management off-site facility. Maintains department Records Transfer Form Files in accordance with the records management programs. Responsible for all requests/retrievals of department records stored in the off-site storage. Participate in Records Management clean out campaign. File CDs containing scanned documents, print the document and archive in binders.

  11. Performs other duties as required by the team to support Quality Assurance Regulatory Compliance activities such as copying documents & send to requestors’ inside/outside the plant. Provide documents requested from incoming, packaging and manufacturing area.

REQUIREMENTS

  • Bachelor's Degree in Science or related field.

  • Minimum of two years of experience in pharmaceutical industry or related preferably with knowledge of c'GMPs and compliance aspects.

  • Fluent in Spanish and English and excellent ability to write in English and Spanish. Good written and oral communication skills

  • Proficient in the use of MS Office applications Word, Excel, Power Point, Outlook , eLIMS and SAP. Data entry skills into Excel spread sheets and/or Microsoft Word .

  • Good data analysis and customer service orientation

  • Available part time position : L-V 1pm- 6pm/ 12pm- 5pm

Why Kelly?

  • Exposure to a variety of career opportunities as a result of our expansive network of client companies

  • Career guides, information and tools to help you successfully position yourself throughout every stage of your career

  • Access to more than 3,000 online training courses through our Kelly Learning Center

  • Weekly pay

  • Four holidays paid by year and Christmas bonus

Apply Today! at http://www.kellycareernetwork.com/

* Must comply with minimum established requirements to qualify.

Why Kelly ® ?

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—

providing you with opportunities to work on today’s most challenging, research-intensive, and relevant

projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help

advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000

scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world

a better place. Let Kelly fuel your career—connect with us today.

AboutKelly Services ®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect

with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,

Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is

committed to employing a diverse workforce. Equal Employment Opportunity

is The Law.