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Scientist-II
Ref No.: 18-06565
Location: Fort Washington, Pennsylvania
Start Date / End Date: 07/01/2018 to 12/31/2018
Position Title: QC Scientist II


II. Position Summary: (Briefly state the objective of this position. Why the job exists)
Provides testing, technical and troubleshooting support in the QC laboratories. These functions include:

Collection, processing, method development and testing of chemical components, bulk products, raw materials, packaging components, finished products, marketed product stability, in-process materials, scale up, validation and cleaning validations to conform with specifications and standard operating procedures (SOPs).

Thorough knowledge of SOPs, USP and other applicable pharmacopeia.

Possess foresight to recognize task needs and performs the trained task without the request of management.

Reviews and/or writes the following documents: APR, SOPs, QSRs, Instrument qualification, protocol/report writing, trending and review/analysis of data.

Performs statistical analysis in support of APRs, Stability, and Product Release.

Complies with cGMPs, safety training and regulations.

Performs more advance technical projects under the supervision of management.

Maintains an environment of respect and teamwork with all coworkers.

The Company’s 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: (Define key accountabilities and/or activities.) Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies’ policies, procedures and guidelines, this position:
• Ensure quality and compliance in all my actions by:
o Attend GMP training on the schedule designated for my role and as appropriate for my role
o Adhere to strict compliance with procedures applicable to my role.
o Exercise the highest level of integrity in the tasks that I perform
o In a timely and prompt manner, identify report and seek correction for deviations noted in my workplace.
o 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.
• May provide statistical analysis in support of the APR and Stability processes.
• 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.

IV. Requirements: (List types of requirements and typical years required)
Education: Bachelor’s Degree in Microbiology, Chemistry, Biology, Natural Science, Medical Technology, or related science is required

Experience: Minimum 2 years 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