Laboratory Technician Position Available In Johnston, North Carolina
Tallo's Job Summary: The Laboratory Technician role as a Validation Area Specialist I in Clayton, North Carolina, offers a pay rate of $25.63/hr on w2 for a 12-month duration. Responsibilities include equipment revalidation, collaboration across departments, and adherence to regulatory regulations. Candidates must have a Bachelor's Degree in Engineering or related field, with 2+ years of validation experience in pharmaceutical or medical device industry. Key skills include effective communication, root cause analysis, quality documentation review, and knowledge of cGMP practices.
Job Description
Job Title:
Validation Area Specialist I Duration:
12 Months (Possible Extension) Pay rate: $25.63/hr on w2 Shift M-F 1st shift
Location:
Clayton, North Carolina
TOP SKILLS PER MGR
1. Equipment revalidation experience 2. Ability to flex schedule (site is 24/7) 3. Ability to physically perform revals as well as associated paperwork
JOB TITLE
Validation Area Specialist (AP/Aseptic Production)
PURPOSE:
Perform revalidation on equipment/processes per approved timelines. Support validation activities associated with changes to existing & new systems. Processes include formulation, sterilization, cleaning, filling & inspection.
ESSENTIAL FUNCTIONS
Perform & review revalidation. Must be able to work & communicate effectively across multiple departments to schedule & perform revalidations. Author and review documents in accordance with local, corporate & regulatory regulations. Collaborate and review
IQ, OQ & PQ
protocols for systems/processes per approved timeframes. Support and/or lead the closure of investigations per approved timeframes using root cause analysis techniques. Participate in teams to help identify root causes of failures & implement corrective actions which address & eliminate potential reoccurrence of the failures. Participate in continuous improvement initiatives using cLEAN tools and methodology Ensure executed protocol data reviewed is accurate & meets documented acceptance criteria. Responsible for Change Requests (CR’s) related to revalidation & other validation activities for AP. Author and review validation procedures, specifications & quality documents for accuracy & compliance. Presentation & support for validation concepts & approaches with audits & inspections. Follow all safety & environmental requirements in the performance of duties.
QUALIFICATIONS
Bachelor’s Degree in Engineering, Computer Science, or applicable scientific or technical degree required. Minimum of 2 years of validation related discipline experience in pharmaceutical or medical device industry required. Experience in quality concepts including technical & compliance review of validation & quality documents preferred. Experience in one or more core validation areas (sterilization, cleaning, process or computer validation) preferred. Experience in cGMP documentation practices & regulations preferred. Basic computer skills including experience in the use of Microsoft word, Excel, etc preferred. Knowledge of statistical methods preferred. Strong oral & written communication skills preferred. Experience with validation test equipment including temperature mapping equipment (for example: Kaye Validator) preferred. Experience in project team collaboration & support preferred. At least one (1) year of demonstrated experience using root-cause analysis techniques to solve problems preferred. Demonstrated expertise in planning/organizing, managing execution, checking results & revising the work plan for complex problems being resolved by cross functional teams a plus.
