QA Validation-CQV

Title: QA Validation-CQV
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, Turnover Packages, SOP's, specifications, traceability matrices, thermal mapping documents, and design documentation.
Provide expertise and solutions to issues regarding CQV Lifecycle documentation in regards for applicable FDA/EMEA Regulations
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 CQV guidelines, policies and procedures for equipment, analytical equipment, utilities, and facilities (Examples: Chromatography Systems, harvest hold tank, Lyophilizers, washers, autoclaves, gas distribution system, HVAC, etc.
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
Strong knowledge of cGMP's 21CFR parts 2010 & 211, knowledge of 21CFR600 - Biologics desirable.
Demonstrated knowledge of ISPE Baseline Guide 5, ASTM E-2500, EU regulatory requirements, and GAMP 5 Validation Lifecycle.
Knowledgeable in risk assessments and process for following well documented and thought through risk-based approaches.
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).
Employment Type: Contractor
Salary: $ 55.00 Per Hour