At Hologic, we're an innovative medical technology company that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we've been able to expand our offerings to empower even more people and champion women's health
What powers our growth across Breast & Skeletal Health, Diagnostics, GYN Surgical and Medical Aesthetics Solutions is also what differentiates us: the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access.
None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities.
While we focus on women's health and well-being, we are committed to having an even broader benefit on the world. Together, we advocate for better health and wellness through solutions that provide ever greater certainty and peace of mind.
Responsible for performing manufacturing activities to support clinical and commercial products. Primarily responsible for filling, capping, labeling in a controlled environment. May be assigned to one or more functional Manufacturing area.
Essential Duties and Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
Setup, calibrate, and operate reagent filling/lyophilization equipment according to SOPs and work instructions
Perform in-process verification checks for fill weight, removal torque, and label placement
Perform inspections of labeled reagents for defects
Maintain detailed and accurate device history records
Complete and forward device history records for review in a timely manner
Follow all safety rules
Complete training requirements in a timely manner and maintain an accurate training record
Perform material handling and staging of materials for process orders
Receive and verify the accuracy of materials transferred from the Warehouse
Understand and execute written procedures in accordance with cGMPs
Prepare cleaning solutions and perform routine cleaning of material staging area, laboratory, lab ware, product totes and laboratory equipment
Responsible for meeting or exceeding quality, productivity and efficiency standards
Maintain accurate inventory of materials, supplies & reagents and perform timely and accurate ERP transactions
Place samples and/or finished goods in appropriate storage areas and notify appropriate departments for pick up (Warehouse and QC)
Operate basic lab equipment
Recommend revisions to device master records and SOP's as needed
Initiate Mechanic Work Service Request Forms
Assist/maintain instrument verification and calibration
Perform cycle counts of materials and maintain inventory accuracy
Assist in training of new personnel as needed
Maintain equipment in a calibrated state by performing simple calibration activities
Other duties as assigned
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required.
Good communication and organizational skills
Technical education preferred
3-5 years' experience in related field
Strong oral and written communication and organizational skills
Must be capable of completing manufacturing records accurately for regulatory requirements
Ability to operate and maintain production equipment and machines
Familiarity with Microsoft Office Applications
High school diploma or equivalent
Previous experience in a laboratory environment and GMP understanding required
Previous experience operating filling/capping/labeling equipment and/or lyophilizers preferred
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.