Job Summary Manage production lines to meet the established production schedule in accordance with Standard Operating Procedures (SOP’s) and Good Manufacturing Principles (GMP’s) while monitoring product to ensure quality standards are maintained.
Job Details This position will be responsible for the following: Comply with all safety regulations and conduct all activities in a safe, efficient manner.
Apply 5S and cGMPs in all areas of responsibility.
Operate high-speed equipment for the manual or automated assembly, filling, packaging and labeling of pharmaceutical products: ensuring adherence to specifications.
Perform tasks that may be verified by an independent individual; or perform inspection/verifications of work performed by others.
Clean packaging rooms and machinery in accordance with SOPs and cGMPs.
Conduct Set-Ups, in-process actions, data entry, and other computer-related tasks.
Complete batch records accurately and documents production volumes in accordance with SOP’s and cGMP’s.
Accept or reject products according to acceptability standards determined by cGMP’s, customer requirements, and SOP’s.
Complete Line Clearances and Change Overs on production lines in accordance with SOP’s and cGMP’s.
Conduct in-process inspections and reconcile incoming and completed components and products to ensure accuracy and accountability.
Perform other duties as assigned.
Incumbent has full authority to make decisions and/or take action that is required to carry out job duties.
Internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements and objectives.
The incumbent must be willing to take temporary assignments as required.
Regulated Responsibilities (including cGMP and EHS) Incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485
– Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.
Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.
Education and Experience: Minimum requirements for this position are: Education High School Degree or equivalent with one year of manufacturing experience.
Experience: Technical One (1) year related work experience, preferably in a high-speed production or manufacturing environment.
Experience: Regulatory Experience working in a GMP regulated environment preferred.
Experience: Systems Basic user knowledge of Microsoft Office, SAP experience preferred.
Experience: Aseptic Experience working in an Aseptic Production environment preferred.
Essential Knowledge, Skills & Abilities: Detail-oriented and self-motivated Excellent hand-eye coordination and manual dexterity.
Excellent math skills; ability to add, subtract, multiply, and divide.
Ability to read, comprehend, write, and communicate effectively in English.
Ability to carry out detailed written or oral instructions.
Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment.
Basic user knowledge and understanding of Windows based computer systems such as Microsoft Office, with an ability to learn other computer-based systems.
Ability to work any shift (up to 12-hours) as required dependent on business needs.
Physically able to continuously stand and walk.
Ability to work in a controlled environment and comply with gowning requirements such as: hairnets, beard covers, safety shoes, googles and/or safety glasses.
Ability to interpret work instructions and standards of work independently.
Physically able to lift up to 40 lbs.
for men and 35 lbs.
for women.
Physically able to bend, climb, lift, squat, stoop, and stretch to reach frequently.
Effective and efficient operation of manual and automated production equipment.
Ability to use, clean, and store tools and other devices required for the performance of the job in a manner which prevents damage to the tools and / or equipment.
compensation includes 15% shift differential
– sign-on bonus for overnight shifts in Waco for external candidates only, to be paid out after completing 60 days of employment