quality assurance associate i.

job summary:
As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines and for covering seven major therapeutic areas. To be a part of the science that is changing the world, apply now!

 
location: Ridgefield, New Jersey
job type: Contract
salary: $40.00 - 42.50 per hour
work hours: 7 to 3
education: Bachelors
 
responsibilities:
- Make sound decisions regarding packaging inspections, rework operations and final

disposition of incoming materials according to policies and procedures with

minimum supervision.

- Perform audits, walk-throughs, GEMBAs, technical coaching

- Support Lead and Manager with tasks as needed (Change Control, Deviations etc)

- Must passed visual syringes/vials certification to perform manual visual AQL inspection of filled product.

- Strategically prioritize in-coming inspections to accommodate Manufacturing's needs.

- Act as liaison with suppliers as necessary to resolve quality issues.

- Provide quality expertise and support to the Packaging and Manufacturing Operations

site (Quality Oversight, logbook/AQL Inspection Forms review, solve issues real time

with operations personnel, etc.) AQL - stands for Acceptable Quality Level

Three inspection levels are generally used: I, II, III. There are an additional four special levels - S1, S2, S3, S4 - that may be used where relatively small sample sizes are necessary, and also where larger sampling risks can be tolerated.

- Participate in process improvements to eliminate redundant inspections/ sampling.

- Well versed in ANSI.ASQ Z1.4 sampling plans (ANSI.ASQ Z1.4 is a Sampling Procedures and Tables for Inspection by Attributes. It is an acceptance sampling system used to inspect incoming, in-process, and final products to determine compliance with established acceptance criteria through the section of random samples of items.

- Familiar with AQL sampling, normal, reduced, and tightened inspections and switching

rules.

- Working knowledge of cGMP as it relates to inspection activities.

- Possess the ability to read and interpret component drawings and use measurement

tools such as calipers and micrometers.

- Possess the ability to evaluate certificate of analysis of chemicals/raw

materials/packaging components.

- Collaborate with Purchasing Department and Suppliers to resolve incoming inspection

paperwork discrepancies and shipping issues.

- Practice safe work habits and adhere to safety procedures and guidelines

- Maintains compliance to policies and procedures.

- Knowledge of medical device or drug packaging operations.

 
qualifications:
Required:

- High School Diploma (or higher)

- 1-3 years of QA experience, will accept more years of experience

- CGMP/regulatory compliance

- Incoming inspections, boxes inserts, vials, etc.

- CAPAS, deviations, change controls,

Preferred:

- Experience with SAP ERP system, iLearn, QualiPSO and STARLIMS a plus.

- Experience with writing investigations

#LI-JW1

 
skills: Quality control, Quality Assurance, CAPA, GMP (Good Manufacturing Practice)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.