The main functions of the Sterile Filling Area are to set-up and operate filling/sealing-automated equipment in a clean room environment. In addition clean and sanitize the equipment and areas that are utilized for the filling/sealing operation. Operation occurs in a clean room environment and is governed by strict standards of sterility and regulatory agencies.
The operators in this area aseptically fill parenteral products in liquid and lyophilized (freeze-dried) form, seal the vials, and ensure that Standard Operating Procedures (SOP’s) and current Good Manufacturing Practices (cGMP’s) are followed at all times.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
Comprehend and follow SOP’s, cGMP’s, and good aseptic technique to produce sterile quality products.
Aseptically assemble and operate automated filling equipment
Aseptically assemble and operate automated sealing equipment
Aseptic gowning for various classifications of clean room areas
Documentation and review of associated paperwork for accuracy and clarity
In-process inspection or pre-inspection of vials as necessary
Stock gowning materials for gowning
Cleaning and sanitization of work areas
Working with peers to help train each other as directed by Production Management
Other miscellaneous duties as required by supervisor
This job has no supervisory responsibilities.
Education and/or Experience
Associates Degree or higher; prefer additional one to two years’ experience and/or training in a production, manufacturing or cleanroom environment; or equivalent combination of education and experience.
To perform the job successfully, an individual should demonstrate the following competencies :
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
Oral Communication - Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Participates in meetings.
Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
Visionary Leadership - Inspires respect and trust.
Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; Effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
Business Acumen - Aligns work with strategic goals.
Cost Consciousness - Conserves organizational resources.
Diversity - Shows respect and sensitivity for cultural differences; Promotes a harassment-free environment.
Ethics - Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; Supports organization's goals and values; Supports affirmative action and respects diversity.
Judgement - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles.
Planning/Organizing - Uses time efficiently; Plans for additional resources; Sets goals and objectives.
Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions ; Uses equipment and materials properly.
Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals.; Completes tasks on time or notifies appropriate person with an alternate plan.
Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.
Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence.
Basic Math Skills required
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
To perform this job successfully, an individual should have knowledge of Manufacturing software; Spreadsheet software and Word Processing software.
Certificates, Licenses, Registrations
Other Skills and Abilities
Must pass Wonderlic Test at 12th grade level or higher.
Must be able to follow detailed instructions, utilize good written/communication skills and have some basic computer skills.
Ability to perform documentation duties and projects that relate solely to the filling department.
Must pass background check and drug screen as well as physical (company paid). Failure to pass any of these requirements could result in withdrawal of offer or termination of employment.
Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to stand; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to walk; sit; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is regularly exposed to fumes or airborne particles. The employee is frequently exposed to moving mechanical parts and toxic or caustic chemicals. The employee is occasionally exposed to extreme cold; extreme heat; risk of electrical shock; risk of radiation and vibration. The noise level in the work environment is usually loud.
OSO BioPharmaceutical Manufacturing, LLC - 2 years ago