Quality Control Specialist

Quality Control Specialist Job Description Template

Our company is looking for a Quality Control Specialist to join our team.

Responsibilities:

  • Reviewing HACCP, SSOP and other QA records;
  • Assisting the Quality management team by running reports and collecting required data;
  • Place products on hold when non-conformance has been noted;
  • Perform annual inventories of retain samples and annual defrosts of temperature chambers;
  • Collaborating with others to carry out work;
  • Perform sample receipt and sample storage;
  • Participate in the receipt and shipment of cell banking vials;
  • Manage documents (Standing Operating Procedures (SOP’s) and Test Methods and assay forms);
  • Creation, revision and review of the Good Manufacturing Practices (GMP) documentation;
  • Proven analytical and problem solving skills, with the ability to make independent decision making skills;
  • Ability to work with minimal supervision in a proactive style;
  • Accounting skills with experience in preparing account reconcilements;
  • Responsible for citing all errors encountered during the review process and informs the individual responsible for the error so it may be corrected;
  • Identifies and communicates training opportunities/performance issues identified though analysis of repetitive errors to management for resolution;
  • Assist management with identification and development of procedures and process improvements.

Requirements:

  • Advanced years previous experience in a Good Manufacturing Practices (cGMP environment), preferably a quality control laboratory;
  • May determine methods and procedures on new assignments and may provide guidance to lower level personnel;
  • Strong oral and written communication skills;
  • Mature, self-motivated team player;
  • Ability to train and teach on basic procedures; demonstrates appropriate procedures;
  • Experienced and proficient in Microsoft Suite, Laboratory Information Management System (LIMS) & Trackwise;
  • Strong organizational and time management skills to carry out multiple assignments;
  • High school diploma or equivalent;
  • Experience working in a team environment;
  • Strong written and verbal communication skills;
  • Minimum of 1 year experience in a quality reviewer role;
  • Understanding and application of Good Laboratory Practice and Good Manufacturing Practice;
  • Prior experience reviewing the performance of environmental and water systems monitoring;
  • Experience with aseptic technique.