Newark
Job DescriptionQC Analyst II Newark CA, 94560 10 Months JOB SUMMARYDuties: JOB SUMMARY The QC Analyst II is responsible for environmental monitoring (EM) and microbiological testing in a GMP aseptic and non-sterile manufacturing cleanrooms, including high-potency API operations. Perform environmental monitoring and utility sampling while upholding aseptic practices, data integrity (ALCO/ALCOA+), and safety controls for potent compounds. The analyst partners closely with Manufacturing and QA to protect product quality and patient safety. Additional responsibilities include peer reviewing laboratory documentation for accuracy, performing routine laboratory and equipment maintenance in accordance with policies and procedures, and supporting documentation management. Support team members to meet group goals. Participation in special projects and/ or instrument problem-solving as needed. • Perform environmental monitoring, sampling, and analysis of production clean zones using particle counters, contact plates, swabs, and microbial air samplers., • Perform utility water sampling and testing (conductivity, TOC, bacterial endotoxins, and bioburden), • Perform microbiological testing such as microbiological examination, endotoxin, growth promotion, etc., • Perform sample log-in, assignment of sample tracking number, and coordinate shipment of samples to outside test labs., • Perform QC Laboratory testing accurately, according to schedule, and as per written procedures. Record all data, observations, and QC results accurately with attention to detail., • Accurately document all data in assay worksheets, laboratory notebooks, and electronic systems (e.g., LIMS) in accordance with ALCO+ data principles and cGMP guidelines, • Other duties as assigned., • Work independently as well as collaboratively within the QC department and cross-functional departments., • Support aseptic process validations and gown certification processes in coordination with manufacturing staff and Quality Assurance., • Performs enumeration, characterization, and speciation of microorganisms recovered from samples., • Provide lab maintenance and support to ensure cGMP compliance on a regular basis., • At minimum, 2+ years of microbiological, biological, and chemical method execution within a GMP environment., • Experience with aseptic manufacturing principles, pharmaceutical water system, and environmental monitoring programs., • Previous cGMP, solid technical training, and troubleshooting experience. COMPETENCIES Key Competencies: · Integrity, Trust, Ethics & Values · Results oriented · Strategic Skills · Organizing/Priority Setting · Business Acumen · Planning · Decision Quality · Customer focused · Conflict Management · Interpersonal Savvy · Negotiating · Problem Solving · Listening & Approachability · Partnering WORK ENVIRONMENT & PHYSICAL DEMANDS This section of the job description is required by the American with Disability Act, (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship. A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.” • Prolonged periods of standing and/or sitting at a workstation, • Must be able to regularly lift and/ or move up to 25 pounds Minimum Required: • Bachelor of Science in Microbiology, Biology, or a related pharmaceutical biotechnology discipline #TB_PH #ZRPHCompany DescriptionFounded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct/contractual relationships with all our clients. Please visit our website or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CAFounded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct/contractual relationships with all our clients. Please visit our website or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CA