Quality Associate II, Batch Record Review

BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Quality Associate II, Batch Record Review to work for a leading contract manufacturing company.
 
Quality Associate II, Batch Record Review
 
Responsibilities
  • Reviews manufacturing and packaging records for completeness
  • Reviews and organizes all analytical and in-process data for completeness
  • Reviews manufacturing log books associated with batch records
  • May open TrackWise events and review deviations associated with product ready for release
  • Responsible for the maintenance and storage of all batch records
  • May be involved in the creation of Certificate of Compliance, when needed
  • May release bulk products to coating and packaging for further processing
  • Functions may include release of finished products, raw materials, and issuance of MBRs
  • Release brand product for distribution as needed
  • Generates disposition documentation for generic release
  • Identifies complex errors such as calculation conversions
  • With demonstrated competence, reviews production records in a timely manner and resolves errors in collaboration with manufacturing personnel
  • Reconciles BR entries with other documentation/ procedures
  • Notifies supervision concerning errors that may need further investigation
  • May create release labels and place on product cartons; reconciles labels against quantities as needed
  • Assists in inventory reconciliation for controlled substances
  • Documents batch errors and provides error tracking to management
  • Assists in collecting other data as required for business metrics
  • Able to identify potential issues and trends and escalate to supervision
  • Inputs data into the APR database
  • Prepares daily activity database entries in CME
  • Develops and implements standard work practices and/or SOPs for document control across the facility to ensure a consistent approach
  • Becomes a Qualified Trainer and trains junior/peer Quality Associates
  • Provides compliance support and training to other personnel
  • Assist in ensuring compliance to training metrics for Quality Associates
  • Participates on non-conformance teams to resolve issues
  • Participates in process improvement initiatives
  • Follows internal processes related to controlled substances
  • Follows all procedures to ensure a safe and compliant work environment
 
Qualifications
  • High school diploma or equivalent with 2 years’ relevant experience OR 
  • Associates degree with 1-2 years’ relevant experience
  • Related discipline and certification in assigned area a plus
  • Experience with statistical sampling methods a plus
  • Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
  • Has solid working knowledge of BPR process and expands technical skills related to BPR process
  • Knowledge of and ability to read and interpret SOPs and function within the scope of procedures
  • Strong understanding of Pharmaceutical Manufacturing and Packaging as applicable
  • Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.
  • Proficiency with math skills and strong experience with computers and software applications required
  • Ability to learn new processes and procedures
  • Able to identify complex error such as calculation conversions
  • Able to reconcile BR entries with other documentation
  • Proof-reading skills; ability to identify errors
  • Able to communicate effectively with other departments, management and operational personnel
  • Customer/Stakeholder focused (understands impact of daily work to compliance and overall business)
  • Ability to read and comprehend documentation and requirements set forth in BPRs
  • Strong basic math skills
  • Attention to detail
  • Strong documentation skills
  • Ability to follow complex processes
  • Physical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
  • Lift 15 lbs.
  • Walk across plant/warehouse
  • Wear appropriate gowning as required
 
If interested, please contact Gavin Lee at (562)495-3200 x4 or send him a copy of your most updated resume at gavin@biophaseinc.com. Please visit www.biophaseinc.com for additional jobs as well!!
 

  • Location: Orange County
  • Type: Contract to Perm
  • Job ID: HS87301213