Job Description

Position: IPQA Associate

Department: Quality

Reports To: IPQA Manager

Location: Cranbury, NJ

Classification: Full time-On site

FLSA Status: Non-Exempt

SUMMARY/OBJECTIVE:

The In Process Quality Assurance (IPQA) Associate will be responsible for supporting IPQA inspections and support continuous improvement for the Quality Management System (QMS) on documentation management, data entry and shipment verification processes at Experic facilities.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Develops, scans, and maintains inspection reports. Maintains detailed records of sampling, inspections testing activities.
• Inputs inspection data managing inspection spreadsheet.
• Performs Shipment Verifications. Shipment verifications include verification of picked and packed materials.
• Manages expiry inventory, labeling materials and communicating with warehouse personnel.
• Manages expiry date changes on material labels.
• Electronically archives supporting documentation of expiry date changes.
• Performs inspection on returned materials as required in return protocols. Manages and maintains return documentation and data.
• Performs visual and functional inspection of materials against statistically based sampling plans using measuring devices such as balances, micrometers, and gauges to determine conformance to specifications. Materials include labels, ancillary materials, primary and secondary packaging materials.
• Labels material for disposition in Warehouse area including Quarantine, Released, In- Process, Finished Goods, Returned Goods, client specific Retain Samples, R&D Use, and Rejected materials.
• Supports Quality Control inspectors in daily activities, assisting with incoming inspections, acquiring samples, and managing inspection and testing documentation.
• Support continuous improvement Experic’s Quality Management System (QMS) and processes, including but not limited to controlled document management, event tracking, change control, CAPA, and regulatory compliance.
• Works closely with SMEs to assist in authoring and reviewing Policies, SOP’s, WIs related to Experic’s Quality Systems
• Works closely with the IPQA manager on continuous improvement projects for Quality Systems activities.
• Supports Batch Record Specialist with batch issuance, batch preparation, and record review as needed.
• Helps to promote a culture of quality, compliance, and accountability mindset, including continuous improvement through the establishment of KPI metrics.
• Support auditing activities for internal and external audits.

QUALIFICATIONS AND EXPERIENCE:

High school diploma, GED or Bachelor’s degree required with a minimum of 3 years of relevant experience preferred. However, in lieu of a degree, three (3) or more years of relevant experience of working in Quality Systems and/or IPQA inspections area activities may suffice.

The candidate needs to be highly motivated, well-organized, and detail-oriented who can work effectively in a fast-paced and multi-disciplinary environment.

Experience of GMP document review, change control, non-conformances, CAPAs, complaints, and Quality Management System maintenance.

Understand the requirements and procedures related to Quality Assurance.

Ability to work flexible hours as needed.

Ability to work under pressure and meet deadlines.

Demonstrated knowledge of industry regulations and best practice standards including but not limited to the following:

US Standards: 21 CFR Part 210 & 211 - 21 CFR Part 11 - 21 CFR 1300 - 21 CFR Part 820

EU standards: EU Annex 11 - EudraLex Volume 4

ISO Standards: ISO 13485 - ISO 14971 - ISO 17025.

COMPETENCIES/SKILLS:

• Read, write, review, and interpret documents such as standard operating procedures, manuals, work instructions, specifications, protocols, quality agreements and contracts.
• Legible Handwriting.
• Communicate clearly in writing and orally.
• Excellent analytical, prioritization, multi-tasking, communication, strong leadership skills, and the ability to work independently with limited supervision.
• Ability to support internal and external audits (e.g., FDA, Notified Body, Customer Inspections) from a documentation perspective.
• Demonstrated effective collaboration and teamwork.
• Demonstrated experience working in a cGxP environment.
• Successfully completes regulatory and job training requirements.
• Computer skills:
• Enter data into computer using software applications for data entry, data analysis, statistical analysis, and word processing.
• Work and be proficient with e-mail systems.
• Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.
• Handle problems quickly and efficiently.
• Excellent knowledge of basic computer tools (e.g. Office suite, Internet, email)
• Ability to communicate with department mangers.
• Excellent motivator

SUPERVISORY RESPONSIBILITIES: None

WORK ENVIRONMENT: This job operates in a manufacturing/packing/warehouse setting.

PHYSICAL DEMANDS:

Office Environment (standing and sitting) requiring minimal physical exertion.

While performing the duties of this job, the employee is frequently required to stand, walk, use hands to touch, handle or feel, and talk or hear.

The employee is occasionally required to sit and reach with hands and arms.

Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

TRAVEL: Not applicable

SALARY RANGE: 50,000 to 70,000

If you’re interested in this position, please email [email protected] with your resume and any relevant documentation, including proof of certifications if specified in the job description.

Be sure to include the position title in the subject line of your email.

We look forward to connecting with you!

The job demands described here are representative of those that must be met by an employee to successfully perform the functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This job description is not intended and should not be construed to be exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job. It is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations and for establishing performance standards. The percentage of time spent performing the various job duties is not absolute. The incumbent shall perform all other functions and/or be cross trained as shall be determined by the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. This document is not a contract for employment.

EXPERIC is an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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