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,