Perform daily operation cleaning, sanitization and decontamination of the Parenteral Manufacturing Areas and equipment :
Cleans and sanitizes sterilize manufacturing area rooms and equipments.
Documents the cleaning process following the good documentation practices.
Sterilizes equipment to be used in the cleaning process by operating an autoclave.
Prepares germicide and sporocidal solutions as per SOP.
Filtrates isopropyl alcohol 70%, when necessary.
Maintains inventory and request all necessary components and operating materials in order to assure continue operations.
Completes preparation of cleaning equipment used for production activities.
Maintains good communication with support departments in order to comply with all the manufacturing needs.
Performs fogging process with sporocidal solutions through the Air handling Unit ducts.
Checks and verifies manufacturing equipment, installation, calibration, and connections.
Tests the filter bubble point before and after the IPA filtration process.
Cleans and unloads the autoclave every week.
Completes all required production documentation in a legible, error free and on time manner following good documentation practices.
Attends to all mandatory training meetings for cGMP’s, EHS and Company Policies.
Coordinates, checks and verifies all manufacturing equipment installation, calibration and connections.
Performs duties related to support other areas as required by the supervisor
Attends and actively participate in meetings and trainings for department communication, safety, security, and quality.
Participates in production scheduling meeting.
Follows up on progress of activities (e.g. documentation approval) with support departments and inform status to the supervisor.
Assists other areas within operations and at the site.
Performs Environmental Health and Safety duties required by the job as follow
Maintains housekeeping within controls and aseptic environments, according to procedures.
Handles Hazardous and Non hazardous waste according to EHS procedures.
Supports Environmental Monitoring Program by assuring sampling collection within manufacturing area on established timeframe.
Supports Annual Requalification Program by assuring plan execution on established timeframe.
Maintains the reusable garment program inventory control.
Requirements:
High School Diploma
One (1) year experience in Parenteral or manufacturing processes Knowledge of Aseptic Processing Technical skills.
Willing to work irregular hours, rotative shifts, weekends and holidays when necessary.
Understanding of basic science concepts as applicable to the process/product and their impact in product quality.
Proficiency using computer, software, and/or automated equipment as related to assigned functions.
Willing to learn new Computerized, PLC control equipment, procedures and new scientific processes.
Ability to collect numerical data and skill in basic mathematical applications (basic calculations such as additions, subtractions, multiplication, division, rounding, average and yields)
Ability to maintain housekeeping and handles waste according to procedures.
Ability to maintain daily production and labor data in computerized system.
Ability to follows the daily production schedules.
Basic knowledge in steam sterilization, depyrogenation, filtration sterilization, lyophilization preferable.
Knowledgeable in cGMP’s, process area, documentation, safety, EHS and hygiene practices.
Ability to work with minimum supervision, take decisions to resolve day-to-day problems in accordance with regulations and internal procedures.
Ability to communicate via multiple channels and with varied audiences ( team members, FDA, EMEA, OSHA, senior leaders).
Ability to read procedures and documents in English/Spanish Text (e.g. SOPs, Batch Records, etc.)
Ability to operate pharmaceutical manufacturing equipment.
Skill in navigating through and performing transactions in mfg computer systems (HMI, hand held computers).
Knowledge of the basic theory supporting environmental monitoring and in process test and impact of results in product quality.
Understand the impact of temperature, humidity and pressure control and monitoring within an aseptic area. Has knowledge of room classification criteria and specific room’s classification.
Strong organizational skills.
Able to wear sterile gowns, full face mask, and full face respirators where required, use Latex/Nitrile Gloves and disposable uniforms.
Able to move objects such as lifting, carrying, pushing and pulling (25-60 pounds).
Ability to operate pallet jacks.
Position Handles Hazardous Materials.
Notes:
Responsibilities and accountabilities will vary for all positions and the scope of individual roles may not be limited to the contents of this position description.
This position will require the employee to work with chemical, radiological or biological agents that may be hazardous to health if mishandled (including agents who made potentially affect reproduction or the fetus or nursing infants). Employees will be required to follow all safety procedures and use personal protective clothing/equipment where specified.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers health benefits that include vision, dental, and pharmacy. Additional benefits offered to eligible employees include a 401K retirement plan with employer matching, a referral bonus program, and an EAP (Employee Assistance Program). SPECTRAFORCE provides unpaid leave as well as paid sick leave and vacation when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at benefits_pr@spectraforce.com if you require reasonable accommodation. At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $12.38/hr.
