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

bHhvOVJTY1BhZG5lYUlSNkdlMkZFNVlIZnc9PQ==
  • 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

Samuel Contract Staffing

Substance Abuse Counselor Job at Samuel Contract Staffing

 ...Behavioral Health Supervisor, the Medicaid Assisted Treatment Program Counselor engages the patient in the initial and ongoing treatment...  ...with minimal two (2) years of satisfactory experience as a Substance Abuse Counselor. CASAC (Credentialed Alcoholism and Substance... 

Marco's Pizza

Pizza Delivery Driver Job at Marco's Pizza

 ...Marco's Pizza is looking to hire a Pizza Delivery Driver/Pizza Maker. About Marco's Pizza: We are one of the fastest-growing authentic...  ...have a clean driving record. Must be available to work nights and weekends. Minimum one year prior experience will be a... 

Valentino

Store Manager- Las Vegas Shops at Crystal Job at Valentino

Store Manager- Las Vegas Shops at CrystalWHY WORK FOR VALENTINOA career in Maison Valentino is your chance to grow in a...  ...maximize sales performance to consistently achieve the overall sales target objectives while ensuring operational integrity and monthly... 

Rosso Recruiting

HVAC Outside Sales Representative Job at Rosso Recruiting

 ...Title: HVAC Sales Representative / Lead Generator (MEP / HVAC) About the Role: Exciting opportunity for a mid-tier HVAC / MEP Outside Sales Rep or professional with design experience to grow and thrive in. You'll enjoy a competitive compensation, benefits package &... 

St. Anne School

Long Term Middle School English Substitute Teacher Job at St. Anne School

 ...RESPONSIBILITIES: Act as a role model of professionalism in a Catholic environment. Support the philosophy, policies, and goals of the school, as well as the decisions made by the Administration and Board of Directors. Insure the health, safety, and welfare...