Document Control Specialist

Tampa, FL

Posted: 03/14/2019 Job Number: JN -032019-10539
Document Control Specialist

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

Title: Document Control Specialist
Location: Tampa, FL
Industry: Pharmaceutical
Hours: 1st Shift Monday-Friday, 8am-5pm
Salary: $18.00/hr.-$22.00/hr.
Employment Type: Contract to hire opportunity

Environment: This client is one the world s leading suppliers to the pharmaceutical, biotech and specialty ingredients markets. We create products that support a healthier lifestyle and enhance ones quality of life. Isn t this a company you want to work for?


Summary:
  • Responsible for issuing database control numbers
  • Assists in document lifecycle through creation, editing, review, issuing and archiving in respect of lab notebooks, research reports, process descriptions, logbooks, batch records, SOPs, test methods, Batch Records, Protocols/Reports, Specifications, Equipment Files, Logbooks and Training Files
  • Writes SOPs and manages templates with support from specialist colleagues
  • Identifies compliance/non-compliance with procedures and resolves necessary amendments to GMP documentation
  • Developing ability to interpret non-standard processes
  • Completes archiving and virtual archiving of documents (scanning, storing files, archiving hardcopy files) to ensure documents can be accessed for customer enquiries, audits and inspections
  • Runs database queries and reports in addition to data entry
  • Prepares data for audits/inspections and provide back room support
  • Builds close links and working relationships with internal customers in other departments
  • May train new staff in use of company systems
  • Provides administrative support for deviation management, investigations, CAPAs and change requests
  • Developing ability to interpret and apply cGMP regulations
  • Normally receives general instructions on routine work and new projects or assignments
  • Reviews Batch Record format
Qualifications:
  • Minimum high school diploma, AA/AS or BS degree preferred. If one has certifications in ACCA, GPHR, CIPS or PGMP this is preferred
  • Minimum 4 years of pharmaceutical and/or related industry experience
  • Experience working within a CMO or CDMO is highly desired
  • Ideal candidate will have experience working/supporting both a laboratory and manufacturing environment
  • Adherence to cGMPs is required at all times during the manufacture of clinical and commercial product. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.
  • Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site.
  • Contributes to a positive work environment, able to deal with deadlines, stress, mult-tasking
  • Great communication skills internally and externally to clients/customers
  • Acts as a reliable and dependable member of the team
  • Strong English writing and editing skills.
  • Consistently delivers goals while monitoring KPIs with supervisor
  • Is willing to take on new challenges, be a team player and problem solver

EOE/ADA
Search words: QA, quality assurance, batch records, documentation, deviations, CAPAs, specifications, logbooks, audits, inspections, GMP, pharmaceuticals
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