What are the responsibilities and job description for the Quality Associate position at SaniSure LLC?
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:
The Quality Associate position supports and maintains a variety of projects and ongoing quality assurance responsibilities as required by the SaniSure Quality Systems and manufacturing processes.
ESSENTIAL FUNCTIONS:
- Complete all activities involving quality inspections and compliance with applicable regulatory requirements.
- Initiate nonconformance reports (NCR).
- Fulfil all aspects of testing related to manufacturing and ensures that all inspections are performed and documented as per the appropriate procedure.
- Incoming inspections
- In-process inspection
- Final Inspection release of finished goods
- Document review
- Supports cross functional departments investigate potential non-conformances observed
- Review, organize, and scan Batch Records and supporting documents within the Document Management Systems.
- Create the generation of product Certificate of Compliance (CoC).
- Assist in the creation of product labels.
- Validate logs, and other data to track and flag quality concerns and improvements.
- Ensure documents are entered in the quality databases, scanning, indexing, filing and archiving.
- Conduct logbook documentation audits for GMP regulated logs and SOPs.
- Perform other duties as assigned.
QUALIFICATIONS:
- Three plus years’ experience with technical documentation for quality activities in the areas of the Quality manufacturing including quality inspections, corrective actions, and change control in a pharmaceutical or medical device environment.
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.
