QA Documentation Clerk

Miami, FL

Posted: 05/21/2020 Job Number: JN -052020-11633

Job Description

QA Documentation Clerk

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: QA Documentation Clerk-multiple shifts
Location: Miami, FL
Industry: Pharmaceutical
Hours: Monday-Friday; 2nd shift; 2pm-10:30pm and 3rd shift 10pm-6:30am (must be open to OT, weekends)
Salary: $15.50/hr.- $16.25/hr.
Employment Type: 6 month contract with the possibility to go permanent

Overview
What needs to be done in order to achieve desired results.)
Responsible to maintain production documentation following cGMP and FDA guidelines and ensure that protocol if followed for removal of documents from Batch Record Repository Room.

Responsibilities
  • Request Batch Record release for Production
  • Generate CR s (Change Requests) for MBR s (Master Batch Record) , ie. Quantity changes and updated records.
  • Responsible for Batch Record issuance for Production department.
  • Responsible for Packing Label issuance for Production department.
  • Assist with Batch Tracker entries.
  • Assist Production Supervisors with Batch Record reviews and corrections.
  • Assist with SOP training.
  • Responsible for maintaining logbook supplies.
  • Maintain and upkeep of the Batch Record Repository room.
  • Other duties as assigned
Qualifications
  • Minimum three years within pharmaceuticals, vitamins/nutraceuticals, industries
  • Excellent knowledge and understanding of cGMP, FDA, and DEA regulations.
  • High School Diploma or equivalent.
  • Excellent knowledge of Windows, Word and Excel.
  • Able to effectively communicate in English written and oral.
  • Good analytical and observation skills.
  • Good knowledge of basic mathematical skills, including measurement.
  • Able to multi-task.
  • Able to follow routine verbal and/or written instructions.
  • Able to work under pressure and meet deadlines.
  • Must be detailed oriented.
  • Must have understanding and knowledge needed about safety SOP s and the requirements for the position to ensure a safer working environment. All precautions and processes must be adhered to in order to maintain a high level of safety compliance.
EOE/ADA
Search words: batch records, manufacturing, production, FDA, GMP, documentation, quality, MRBs, change request, logbooks

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