QA Validation-CSV Job at LS Solutions, Ridgefield Park, NJ

TVl1dFJlSml0TVhIcHlkZ3dMbFZGZ1hU
  • LS Solutions
  • Ridgefield Park, NJ

Job Description

Title: QA Validation-CSV
Duration: 12-18 Months with possible extension ON-SITE
Location: Ridgefield Park, NJ 07660

POSITION DESCRIPTION:
Essential Functions of the job:
Assist in development, review, and approval of cGMP documents including, but not limited to: Master Validation Plans, FAT/SAT documents, SOP's, specifications, design documentation, and validation protocols/reports.
Provide expertise and solutions to issues regarding Computerized System Validation Lifecycle to ensure compliance to 21 CFR Part 11, Eudralex Annex 11 and applicable FDA/EMA Guidance's on electronic data integrity.
Support validation activities for project activities including review of validation documentation (FAT, SAT, URS, SDS, IQ, OQ, PQ) and attendance at validation activities.
Provide QA support to enforce CSV guidelines, policies and procedures for DCS, analytical equipment, and IT applications (Examples: OSI PI, SCADA, EMS, Chromatography Systems, Empower, Single-Use Bioreactors, ViCell, HPLCs).
Possible role as QC Systems Admin.
Employee will be required to work closely with Manufacturing, Validation, Site Automation, Engineer, Quality Control, and Global Technical Operations (GTS) associates.
Ensuring appropriate investigation of validation discrepancies, errors, protocol failures, or validation testing errors requiring documented review and action to reconcile deviations.
Undertaking any other duties for any department within the business, which may be requested by the QA Manager, for which training and/or an explanation has been provided and understood.
Core Competencies, Knowledge, and Skill Requirements

Scientific degree (ideally: pharmaceutical sciences, engineering, chemistry, or related discipline).
Minimum of 5-7 years' experience in validation, biological quality assurance and/or quality control in an FDA-regulated biotechnology or pharmaceutical company with progressive levels of responsibility.
1-3 years in a quality assurance or quality control role in an FDA-regulated company
Working knowledge of cGMP's 21CFR parts 2010 & 211, knowledge of 21CFR600 - Biologics desirable.
Strong knowledge of GxP compliance as it applies to Computer Systems, 21 CFR Part 11, GAMP 5 Validation Lifecycle. Knowledge of cGMP and Data Integrity Guidance utilized in a Quality Operation.
Knowledgeable in risk assessments and process for following well documented and thought through risk-based approaches.
Demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
Good collaboration and good project management skills.
Credible and confident communicator (written and verbal) at all levels.
Customer focused, Strong analytical and problem-solving ability.
Ability to prioritize, demonstrating good time management skills.
Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
Self-motivated, with the ability to work proactively using own initiative.
Highly Desirable: Good IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project and Outlook); working knowledge of SAP.
Employment Type: Contractor
Salary: $ 55.00 Per Hour

Job Tags

Hourly pay, Contract work, For contractors,

Similar Jobs

Crisis24

Residential Security Agent Job at Crisis24

 ...something extraordinary where growth and impact converge. More information is available at Join our team and receive a competitive signing bonus! As part of our commitment to attracting top talent, we're offering a signing bonus. Eligibility for the signing bonus varies... 

Crown Innovations, Inc.

Communications Electronics Engineer Job at Crown Innovations, Inc.

 ...Job Description Crown is hiring a Communications Electronics Engineer to join our team. This position is 20% travel and will be...  ...competitive benefits package including matching 401K, comprehensive medical, dental, and vision plans, and generous PTO. Crown has been... 

Commercial Cleaning Enterprises

Floor technician Job at Commercial Cleaning Enterprises

 ...position open in Mansfield, Ohio for a Floor Technician. This position is full time, 30-40 hours per week. Experience with strip and wax, scrubbing and recoat, mop and buff, and carpet extraction preferred. Work hours will vary, but primarily evenings and weekends. Pay... 

Aura Staffing Partners

1:1 School Nurse CNA Needed Job at Aura Staffing Partners

We are hiring for a 1:1 CNA to work for the Denver Metro area schools!!**FULL-TIME ONLY** A little bit about the position: What is a 1:1 CNA you ask? The school nurse is responsible for planning, implementing, coordinating, and evaluating school health services... 

Lensa

Human Resources Business Partner Job at Lensa

 ...in Carrollton, TX. Apply via Lensa today! Human Resources Business Partner Job Overview Location : United States, Carrollton...  ...and exposure to strategic business activities and wants to be part of a dynamic high functioning HR team. You will partner...