Quality Control Inspector

Job Description

Job Description

ABOUT SANISURE

SaniSure is a multinational manufacturer of single-use bioprocessing solutions (SUT) used in the production of biological drugs, including monoclonal antibodies, cell therapies, gene therapies, and vaccines.

With operations in the U.S. and in Europe, SaniSure operates a leading platform of vertically integrated critical fluid management technologies and integrated solutions.

Its single-use products and system solutions are sold to global pharma and biotech companies and are used from R&D through full-scale commercial cGMP manufacturing of among the most innovative large molecule therapeutics and vaccines.

This role is expected to be on-site.

We continue to be on a robust growth trajectory, via both organic and inorganic growth, as the company capitalizes on increasing global demand and continues its transition from a component manufacturer to an integrated systems and solutions provider.

Our primary offering includes high-value assembly solutions and a portfolio of market-leading products, including PharmaTainer bottles and carboys and related assemblies, Mixed4Sure mixing solutions, Flex4Sure bags and bag assemblies, Fill4Sure needles and needle assemblies, fittings, clamps and a wide range of silicone, braided and thermoplastic tubing solutions.

The company has a growing portfolio of innovative solutions serving fast-growth applications, such as cell and gene therapies.

SaniSure is a high-growth, nimble and innovative company with a strong customer and market focus. Join us and grow your career at SaniSure!

SUMMARY :

Performs quality control inspections in all aspects of operations, checks, and test during the manufacture of products. Inspect incoming materials, and products at different stages of production.

Records observations and make recommendations for improving processes.

ESSENTIAL FUNCTIONS :

• Responsible for all activities involving quality inspections and compliance with applicable regulatory requirements;
• Initiate nonconformance reports (NCR).
• Performs all aspects of testing related to manufacturing.
• Incoming inspections
• In-process inspection.
• Final Inspection release of finished goods.
• Document review.
• Supports cross functional departments investigate potential non-conformance’s observed
• Ensures that all inspections and procedures are properly completed and documented.
• Perform pre and post-inspection of product gamma irradiation process.
• Approve or reject raw materials with respect to quality standards and communicate results to all pertinent parties.
• Initiate nonconformance reports (NCR) for all non-conforming material identified throughout operations
• Prepare and submit Metrics reports to the quality supervisor or QC lead
• Comply with all safety requirements ensuring work areas meet standards.
• May be required to report to multiple facilities within a 2-mile radius.
• Job Order document review and release
• Other duties as assigned

QUALIFICATIONS :

• High School Diploma or equivalent with 2+ years of experience in quality control inspections.
• Understanding of global pharmaceutical product regulations with experience with ISO 9001 and / or 13485 : 2003 and 21 CFR Parts 210 and 211 and / or Part 820.
• Demonstrated ability to perform GMP operations following detailed SOPs, maintaining training, and good documentation practices.
• Minimum of 0-2 years’ experience with technical documentation for quality activities. This experience should be in the areas of the Quality manufacturing that includes quality inspections and corrective actions in a pharmaceutical or medical device environment.
• Solid organizational and planning skills required.
• Ability to communicate effectively, verbally and in writing, demonstrate good interpersonal skills interdepartmentally and with external vendors and contractors.
• Must be able to work effectively and efficiently in a team environment.
• Must have the following personal attributes : integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
• Must display personal accountability for results and integrity.
• Must display eagerness to learn and continuously improve.
• Must have uncompromising dedication to quality.
• Good general mathematical skills.
• General knowledge and use of measuring devices such as calipers, tape measures, rulers, pin gauges

SaniSure is an Equal Employment Opportunity Employer.

SaniSure does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age, military and / or veteran status or any other basis protected by federal or state law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at humanresources@sanisure.

com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis.

Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.