Production Clerk

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients.

Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview The Production clerk will be responsible for data entries in SAP and reporting any issues, and reviewing all manufacturing-related SAP transactions, at a minimum. Assist Manager and Supervisors on the daily production schedule, reviewing data in batch records and executed process related documents for any required corrections, tracking manufacturing hours, prepping batch records, required paperwork, labels and coordinate with other departments for future needs, assist supervisors with ensuring that we have proper materials on hand for production, adjust the schedule as needed and fulfill other administrative or office duties as needed.

Main Responsibilities Checking SAP transactions for accurate end of shift entries and tracking issues. Complete end-of-shift batch record reviews and finished batch record reviews. Maintains the manufacturing operations in compliance with the current regulations, quality work instructions and policies. Monitors and maintains a safe working environment in all manufacturing operations according to Company safety policies and procedures.

Enforces that proper GDP (good documentation practices) and maintenance of records are followed by the manufacturing team members. Interfaces and assist other Departments as required. Performs other duties as assigned by the Manufacturing Manager. Work with the QA-Manager to expedite batch record review process, and Investigations that may arise during production.

Track daily production machine/labor hours in SAP (ensure that each shift inputs the data in SAP). Ensure that all returns are correct and put into SAP correctly. Ensure all tasks are completed and data in SAP is accurate to perform Usage decisions. Data entry in the Daily Production Report and or in SAP. Reviewing SAP and ensuring that all consumptions, yield, and scrap has been entered into the system.

Prepping batch records, paperwork, and labels for batches. Request new pages from doc control and review the pages prior to use for correct information. Reviewing data in batch records and work on getting corrections. Assist with documentation such as bi-annual procedure reviews, events, non-conformances, and/or CAPAs.

Report weekly or monthly status of manufacturing runs from SAP. Able to work after hours and weekends when needed. Skills and Qualification High school diploma or GED. Associates degree preferred. Two years of relevant administrative experience. Excellent computer skills, especially typing. Be willing to work overtime occasionally.

Quickly adapt to new direction or new responsibilities as needed. Knowledge of cGMPs in an FDA regulated environment. Knowledge of OSHA, NFPA guidelines for safe practices. Maintaining a clean and orderly work area. Understanding and following written and oral instructions. Communicating clearly and concisely, both orally and in writing.

Need to be extremely organized, logical, and methodical. We Offer Competitive compensation package Modern working environment with state-of-the-art facilities and technologies Challenging assignments in a fast growing and innovative industry Position in a dynamic, international team of highly skilled professionals Various opportunities for personal and professional development within a global organization Please note that SHL is a drug free employer.

This offer of employment is contingent upon your successful completion of various preemployment screenings, including, but not limited to, a drug test, employment verification, reference checks, and a criminal background check. For more information on SHL Medical, please visit: shl-medical.com