Operational Quality Control Laboratory Manager

USA, Middletown,Delaware

The Datwyler Sealing Solutions Division is a leading supplier of bespoke sealing solutions to global market segments such as Healthcare, Automotive, Civil Engineering and Consumer Goods.  This is built on leading material, engineering and process know-how and the worldwide presence with own production locations. With a global manufacturing footprint, sales in over 100 countries and more than 5,000 employees, the company generates an annual revenue in excess of 500 million Euro.

We value our employees and encourage both personal and professional development.  Our advanced technology environment provides a challenging and satisfying work environment backed by our company values: Entrepreneurship, Respect, Excellence, and bring Value to our Customers.

The position
Initially, the position will hold significant responsibility as part of greenfield project team to assist in the setup of a testing lab in a clean, pharma packaging facility manufacturing elastomer closures. Such closures are typically used as part of a vial, bottle or pre-filled syringe system.

Areas of responsibility
Laboratory Management: responsible for all aspects of day-to-day laboratory operations focusing on efficiency and throughput: develop testing procedures, manage testing equipment, calibration, and installation/validation, ensure safety requirements are met, trainings are up to date and effective, inventory, stock and organize lab supplies and chemicals. Participate in ISO 15378:2017 audits. Play active role in problem-solving to address customer or regulatory quality issues.  

Product Evaluation: will be responsible to organize and supervise quality control analytical and microbiological functions, including incoming material and release, in-process testing, finished product testing, water testing and environmental control in a manner that respects lead time and schedules. Testing will consist of dimensional and visual inspections, physical testing (hardness, density etc.) as well as biological, physiochemical and functional testing as per US Pharmacopeia chapter 381.

Reporting: develop, maintain and report quality metrics, KPIs, statistics and records for QC performance.

Position Requirements: Minimum of a Bachelor’s of science degree in Microbiology, Chemistry or Life Sciences and minimum 5 years of experience in a QC position, preferred 2-3 years managerial experience. The ideal candidate will have excellent knowledge of cGMP, USP and global compendia regulations, excellent verbal and written communication skills, experience with scientific technical writing including authoring and revising SOP's or technical reports, strong leadership skills, able to interact, cooperate, and motivate across departments and functions, work in a fast paced pharmaceutical environment. PC skills including MS Office. SAP preferred.

Travel during training period will be expected.
We offer you the opportunity to utilize your work experience and implement your innovative ideas in a specialized, future-oriented company.  If you are interested in applying for this position please email your resume of qualifications to:  pharma_currentjobs.us@datwyler.com




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