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28 days old

Quality Assurance

Kelly Services
Glenside, PA 19038
**Scientist 1 Biology/Microbiology**


Every day, Kelly Science & Clinical connects professionals with opportunities to advance their careers. We currently have exciting Temporary opportunity with a global leader in the production at Ft Washington PA


Provides testing and technical support in the micro and/or analytical laboratories.


These functions include:



+ Collection, processing, and testing of chemical components, bulk products, raw materials, packaging components, finished products, in-process materials and cleaning validations to guarantee that they conform with specifications and standard operating procedures (SOPs).

+ General knowledge of SOPs, USP and other applicable pharmacopeia.

+ Perform tasks with some guidance, but demonstrate ability to comprehend and perform with experience.

+ Support the review, data generation and/or writing of technical documents such as SOPs, laboratory investigations, test protocols and APRs.

+ Comply with cGMPs, safety training and regulations.

+ Maintain an environment of respect and teamwork with all coworkers.

+ Maintain inventory of testing supplies, temperature monitoring, water samples collection and testing, environmental monitoring and other duties assigned by the Supervisor.

+ The Companys management reserves the right to add, delete or otherwise alter assigned duties at any time. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed 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.


**III. Responsibilities:**


+ Ensure quality and compliance in all my actions by:

+ Attend GMP training on the schedule designated for my role and as appropriate for my role

+ Adhere to strict compliance with procedures applicable to my role.

+ Exercise the highest level of integrity in the tasks that I perform

+ In a timely and prompt manner, identify, report and seek correction for deviations noted in my workplace.

+ Embrace a behavior of employee involvement and commitment to doing the job right the first time

+ Systems Knowledge

+ Be a Power User in the applicable systems and roles assigned.

+ Trained to the role in which you are assigned as required for your job function in the applicable systems

+ Utilize tools within MS office and other systems to improve business effectiveness

+ Exposure to & working knowledge of electronic batch records and/or other automated processes/systems (labs)

+ Working knowledge of SAP or ERP system; including other relevant systems per role

+ Working knowledge of an automated system.


Product Knowledge


+ Understanding of product family, product size and put-up, and product characteristics (color, viscosity) associated active and excipient. Critical parameter associated with all processing steps.


Training


+ Can act as SME and be a curriculum owner.

+ Partner with training department to create training materials including curricula.

+ Can act as qualified trainer in specific areas.

+ Participate in all trainings.

+ Ensure all trainings are completed on-time.


Investigations


+ Assists in gathering information and documentation as required.

+ Participates in investigations as required.


Compliance Safety, GMP, Facilities


+ Provide support during regulatory inspections /audits as directed. Support may be in the form of scribes, runner, and document gathering.

+ Attend GMP training on the schedule designated for the role and as appropriate for the role.

+ Adhering to strict compliance with procedures according to the roles and responsibilities.

+ Exercises the highest level of integrity in the tasks performed

+ In a timely and prompt manner, identify, report and seek correction for deviations noted in the workplace.

+ Embrace a behavior of employee involvement and commitment to doing the job right the first time.

+ Strong working GMP knowledge. Communicates and identifies GMP gaps.

+ Can participate in all types of audits & Inspections.

+ Leads areas in ensuring all operations (processes) are completed in a compliant and safe manner.

+ Assists in coordination efforts in case of emergency- spill, fire etc.

+ Takes necessary action to eliminate and immediately address safety hazards. Communicate any observed unsafe behaviors immediately.

+ Understands the safety concerns and promotes a safety conscience culture for their job function.

+ Wears the appropriate PPE when working in manufacturing and other hazardous working environments and advocates standards of safety.

+ Contributes and attends all EHS programs as assigned.

+ Promptly communicates deficiencies to management.

+ Maintains facility and work area in good working condition.

+ Works with team to ensure all aspects of business remain compliant.


Documentation Management


+ Edits documentation (i.e. Standard Operating Procedures, work instructions) as necessary.

+ Perform/assist in the completion and documentation of the process steps as per the documentation directives.

+ Complete visual verification of the process and document these steps in the appropriate system.

+ Document all activities per the GMP requirements.

+ Process Excellence, Lean, Continuous Improvement, ME2

+ Completes PE/ Lean awareness training.

+ Proactively identifies opportunities for continuous improvement and proposes actions to address these opportunities.

+ Participates and leads continuous improvement implementations and kaizen events. Understands and applies PE tools in daily work activities.

+ Leadership

+ Job expert that less experienced personnel can go to for assistance.

+ Provides leadership in absence of supervisors (for short periods).

+ Assist management through change and transformation activities.

+ Facilitates departmental meetings and may assist in the coordination of other scheduled meetings. In absence of management, attends meetings on his/her behalf.

+ Continuously demonstrates all GLP values; specifically: integrity and credo based actions, self awareness and adaptability, results and performance driven, organization and talent development, and collaboration and teaming. Demonstrated behaviors include: fairness, honesty, consistent and ethical behaviors, empathy and collaboration.

+ Contributes and supports an environment that fosters diversity and inclusion.

+ Exhibits and lives core values and behaviors.

+ Contributes to a climate of open communication, engagement and ownership within team.

+ Builds working relationships

+ Provides feedback to site management

+ Supports strategic and tactical plans in alignment with site's mission and plans.


**Requirements** :


Education: Bachelors Degree is required. Degree in Microbiology, Chemistry, Biology, Natural Science, Medical Technology, or related science is preferred.


Experience: Minimum 1 year of GMP/GLP quality control lab experience in a pharmaceutical and/or OTC and/or regulated environment is required.


Physical Demands: Capable of performing routine laboratory activities. Light to moderate lifting


Knowledge, Skills and Abilities: Basic knowledge/exposure of a LIMS system is preferred


Location: Fort Washington, PA 19034

United States


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-05-27 Expires: 2022-07-14

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Quality Assurance

Kelly Services
Glenside, PA 19038

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