Schott Pharma Jobs in Usa

An Archivist Associate is responsible for: developing and applying acquired job skills needed to support the receipt, login, distribution, disposal, and general oversight of materials submitted for archival purposes; managing study-related records, biological specimens, and study samples; and supporting the archival process by storing, distributing, and maintaining materials within the archive management system.

Essential Duties and Responsibilities

-Perform and document all procedures, materials, and results in compliance with applicable regulatory standards (protocols, methods, SOPs, etc.).

- Identify and communicate any issues with data to management.

- Follow archive security procedures and maintain the integrity of archived materials.

- Perform tasks including but not limited to, organizing, filing, retrieving facility and study related records, biological specimens, and samples.

-Assist internal and external customers with requests for current and finalized study materials under the control of the Archives department.

-Utilize the archival management system for indexing and maintaining materials in the archives or records management area.

- Review departmental and study specific data to ensure adherence to SOPs,

methods/protocols, industry standards, and regulatory requirements, as applicable, in timely manner.

- Follow regulatory requirements for retention of archived materials, in accordance with SOPs and protocols.

-Perform all other related duties as assigned

Minimum Qualifications

Education and Experience: HS/GED/Associate’s degree with 1-2 years of relevant experience.

Certification/Licensure: None.

Other:

- Ability to communicate verbally and in writing at all levels inside and outside the organization.

-Basic familiarity with Microsoft Office Suite.

- Computer skills, commensurate with Essential Duties and Responsibilities, including the ability to learn a validated system.

- Demonstrated effective communication and organizational skills.

Role is with a formulation and delivery team. Will work with research scientists in developing next generation herbicide products and in supporting both R&D activities, and to some extent, commercially launched products.

Evaluates the chemical and physical properties of various organic and inorganic substances in order to investigate their applications in formulated products.

Requires a bachelor's degree and at least 1 year of experience in the field or in a related area.

Has knowledge of commonly used concepts, practices, and procedures within a particular field.

Relies on instructions and pre-established guidelines to perform the functions of the job. Works under immediate supervision. Typically reports to a supervisor or manager.

Diligently records all laboratory tasks performed and related procedures and findings in electronic laboratory notebook system.

Requires hands-on lab experience and interest in doing lab work.

Will work on various projects and follow SOP's and basic lab techniques, using equipment that includes - e.g., pH meters, mixers/agitators, homogenizers, and milling equipment.

***Rheometer and interfacial measurement experience is a plus, as is proficiency in chemistry/chemical engineering principles, including mass-balance calculations.

Some industrial experience in formulation development preferred -e.g., with pesticides, foods, cosmetics, consumer products, and/or paints & coatings.

Role:

The Intake Specialist role works to support the Patient Assistance Program (PAP) through providing initial triaging of patient applications, including data entry and coordination of work through the appropriate channels as determined by established business rules.

Responsibilities:

•Completes the intake process of all applications into Customer Relationship Management System (CRM)

•Associates and tags all images to the patient, data enters all information including patient demographic information, physician information, drug information, and all relevant application data such as income information, household information and insurance information into the CRM

•Conducts initial assessment of application for missing information and completes missing information patient outreach process to obtain required data

•Completes initial assessment of simplified application

•Identify appropriate work flow based upon business rules

•Collaborate cross functionally to ensure processes are followed according to business rules and policies

•Ensure all patient cases are documented in the CRM in accordance with all business rules and policies

•Conduct renewal and year end recertification’s process as determined by the Patient Assistance Program

•Readily assists on special project within job scope to improve reimbursement optimization when requested by management

Manages incoming and outgoing mail

Qualifications:

•High school diploma or equivalent required. College or a 2-year Associate Degree is preferred

•A minimum of 1-3 years’ experience within an office or administrative setting

•Exposure to core insurance (Medical and Pharmacy Benefit) knowledge a plus

•Strong attention to detail and work independently with minimal direction

•High quality customer service skills

•Ability to express ideas clearly in both written and oral communications

Miami, FL - 100% on site Monday-Friday

Study coordinator to support ongoing large clinical study in US. Completes all paperwork required to capture all data as specified by a study protocol, and for ensuring subject safety, understanding, and cooperation during the study process. Interacts with the research site team and other interdepartmental staff. Engages in the entire site operations process, which includes recruitment, enrollment, retention of study participants, data entry and query resolution.

Essential Functions:

• Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines.

• Provides medical care to patients, always ensuring patient safety comes first.

• Schedules subject visits within protocol windows, ensuring scheduling capacity is maximized.

• Performs all defined study activities (i.e., informed consent, screening, and protocol procedures which include but not limited to vital signs, pregnancy tests, height, weight, ECG's, etc.).

• Records all patient information and results from tests as per protocol on required forms.

• Where required, may complete IP accountability logs and associated information.

• Reports suspected non-compliance to relevant site staff.

• Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.

• Promotes the company and builds a positive relationship with patients to ensure retention.

• Attends site initiation meetings and all other relevant meetings to receive training on protocol.

• May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results.

• Logs/completes information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe.

• Gathers and maintains source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded.

• Adheres to company COP/SCOP.

• May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility.

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification in the clinical / medical field

• Must hold a valid nursing license (RN, LVN, LPN) within the country operating. Must be registered with local health care authority.

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’).

Knowledge, Skills and Abilities:

• Solid understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.)

• Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving

• Demonstrated ability to exercise discretion and sound judgement

• Good decision-making, negotiation and influencing skills

• Good communication skills and English fluency will be an advantage

• Good organizational skills

• Good proficiency in basic computer applications

• Good interpersonal skills to work in a team environment

The Intake Specialist role works to support the Patient Assistance Program (PAP) through providing initial triaging of patient applications, including data entry and coordination of work through the appropriate channels as determined by established business rules.

Responsibilities:

•Completes the intake process of all applications into Customer Relationship Management System (CRM)

•Associates and tags all images to the patient, data enters all information including patient demographic information, physician information, drug information, and all relevant application data such as income information, household information and insurance information into the CRM

•Conducts initial assessment of application for missing information and completes missing information patient outreach process to obtain required data

•Completes initial assessment of simplified application

•Identify appropriate work flow based upon business rules

•Collaborate cross functionally to ensure processes are followed according to business rules and policies

•Ensure all patient cases are documented in the CRM in accordance with all business rules and policies

•Conduct renewal and year end recertification’s process as determined by the Patient Assistance Program

•Readily assists on special project within job scope to improve reimbursement optimization when requested by management

Manages incoming and outgoing mail

Qualifications:

•High school diploma or equivalent required. College or a 2-year Associate Degree is preferred

•A minimum of 1-3 years’ experience within an office or administrative setting

•Exposure to core insurance (Medical and Pharmacy Benefit) knowledge a plus

•Strong attention to detail and work independently with minimal direction

•High quality customer service skills

•Ability to express ideas clearly in both written and oral communications

Shift Schedule:

Variable, including weekends and evenings as-needed, typically 8hr duration, always coordinated before shift assignment. The hours will be variable depending on projects at the clinic, and may include days for what would typically be screening assessments or admission assessments, or evenings/weekends for study-related procedures such as dosings, ECG review and interpretation, lab review and interpretation.

Description:

• The duties may include screening procedures such as routine physical examinations of healthy volunteers, ECG interpretation, review of labs, eligibility assessment for prospective study participants, management of adverse events, on-site supervision of investigational product dosing, and related duties.

• Delegates study responsibilities as appropriate to trained study staff

• Possesses a working knowledge of GCP/ICH guidelines, Clinic SOPs, QA/QC procedures, and Investigator 1572 Form

• Reviews Investigator’s Brochure prior to performing any study procedures

• Performs all study responsibilities in compliance with the IRB approved protocol

• Reviews screening documentation and approves subject for admission to study

• Reviews admission documentation and approves subject for randomization

• Interprets ECGs within agreed Sponsor timeline

• Documents all findings in subject specific source documents

• Provides ongoing assessment of the study subject/patient to identify Adverse Events

• Ensures proper documentation and reporting of all Adverse Events and Serious Adverse Events

• Reviews and evaluates all study data and comments to the clinical significance of any out of range results

• Performs physical examinations as part of screening evaluation and active study conduct

• Provides medical management of adverse events as appropriate

• Completes all study documentation in accordance with the study specific requirements

• Communicated with Sponsors and auditors as requested

• Participates in on-call activities as required to ensure adequate medical coverage

• Monitors safety and well-being of study participants at all times

• Provides coverage for the Clinic Principal Investigator

•They should be able to work and thrive in a team-based environment.

The Media Prep team within the STL Transformation Production Team is seeking a highly motivated and fast-paced individual to participate in the critical work to support the pipeline by supplying sterile agar and liquid products to customers around the world in a timely manner. The successful candidate will work with chemical components and different forms of equipment. Desire to work within a team environment is essential to deliver a high-quality product to the customer in a timely manner.

Required Skills: A Bachelor's degree in biology, chemistry, cellular biology or related field is required. Experience working in a laboratory environment is highly desirable. Attention to detail, database experience, ability to work in a team setting, and strong communication and organizational skills are essential. Sterile technique experience is a plus. Must be willing to work up to a 40 hour week with shift times at the discretion of the manager dependent upon production needs.

*Important you are able to work on the 1st shift (6:45 a.m. – 3:30 p.m.) for 4 weeks to train.

Then will be assigned to the 2nd shift (3 p.m. – 11:45 p.m.) or the 3rd shift (10:30 p.m.- 7:15 p.m.) depending on availability.

Job Purpose

Able to perform various inspecting, labelling and packaging operations. Tends machines that perform one or more packaging functions, such as packing, or bundling.

Major Accountabilities

• Handling of components on packaging line and monitors for defects.

• Inspects filled container or package to ensure product is according to specifications.

• May weigh finished products to detect missing components.

• Clears line culls and documents all components discarded.

• Prepares shippers, inspects finished product and packages into shipper. Seals, labels, and stacks shipper.

• Fills cartons, carriers or shippers by hand with product, labels, literature or applicators.

• Performs cleaning tasks on machine during or after machine operation.

• Maintains compliance with SOPs, good documentation practices (GDP), training requirements, Company and safety policies and current Good Manufacturing Practices (cGMPs).

• Verifies correct lot code/exp. date on all pkg. components/finished goods.

• Performs packaging line assignment maintaining line throughput and quality standards.

• Contributes to the team by supporting other lines and roles as necessary to maintain operational efficiency.

• Performs rework/re-inspection of components/finished goods with minimal conversation and focus on product defects.

• Performs various housekeeping duties such as sweeping/mopping floor, cleaning equipment, fixtures, windows, and walls as needed.

• Perform minor adjustment on the equipment and documents work performed.

• Participates in training of new employees.

• Adheres to all applicable procedures, cGMP’s, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.).

• Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and safety Behaviors.

Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, employee requires training under OSHA’s HAZWOPER standard, 29 CFR 1910.120 as an 8-Hour first responder, 24-Hour incident commander, or a 40-Hour incident commander.

In lieu of HAZWOPER training, the employee will receive training on the requirements of the Resource Conservation and Recovery Act pursuant to 40 CFR 265.16.

All employees that have received the above-mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the requirements of RCRA.

Key Performance Indicators (knowledge, skills, and abilities expected of an associate to be effective in this role.)

• Solid English reading/comprehension written and verbal communication skills required to understand and communicate to others detailed cGMPs, SOP's, FI’s, and production equipment cleaning instructions

• Basic mathematical skills and ability to work with numbers to accurately count components, waste and finished goods products.

• Participate in Safety Program by complying with all and preventive measures (i.e., wearing Personal Protective Equipment (PPE).

• Alerts Supervision, Mechanics, Quality personnel to safety, quality and equipment performance problems when they occur.

• Work on projects independently or in a team environment, actively participate on teams ex. (continuous improvement initiatives)

• Perform key roles in a manner that promotes teamwork, is respectful of others and is aligned with the companies behaviour expectations.

• Takes initiative and works autonomously to meet production requirements.

• Continues to develop and learn new skills, which will allow for further advancement within the organization.

Ideal Background

Education: • High School Diploma or GED. Associates Degree preferred. Equivalent experience can be considered in lieu of HS Diploma

Experience: • Minimum of one year production experience

• Ability to lift 30 lbs. and maintain a high level of physical activity

Job Title: HRBP

Job Tyle: Full Time

Job Location: Onsite Cranbury/South Plainfield NJ

Job Responsibilities:

Business Partner:

• Acts as a point of contact for the employees and managers in the business unit;
• Conducts ongoing supply and demand support on current and future staffing and skill needs;
• Source candidates using a variety of search methods to build a robust candidate pipeline;
• Collaborating with department managers to compile a consistent list of requirements;
• Ensure all screening, hiring, and selection are done in accordance with employment laws and regulations;
• Actively identifies gaps, proposes and implements changes necessary to cover labor law risks;
• Manages complex and difficult HR Projects cross-functionally;
• Builds a strong business relationship with the internal client;
• Collaborate with colleagues in the human resources department to develop policies, programs, and solutions.
• Acts as the performance improvement driver and provokes positive changes in performance management;
• Provides day-to-day consultation to leadership on a variety of actions including ER issues, policy interpretation & application, and talent management.
• Responsible for the compensation & benefits policy-making, pension schemes, and social relations;
• Works closely with employees to improve work relationships, build morale, and increase productivity and retention.

HR Operation -

• Oversees end-to-end payroll processing, ensuring accuracy, compliance, and timely payment.
• Manages the onboarding and offboarding process, including documentation, system access, exit interviews, and compliance checks.
• Administers employee benefits programs such as health insurance, pension, leave, and other local statutory benefits.
• Maintains and updates HRIS systems, ensuring data accuracy, timely updates, and reporting for decision-making.
• Supports performance review and talent review cycles, including calibration sessions, follow-ups, and action plan implementation.
• Tracks and reports key HR metrics (e.g., headcount, turnover, attendance, performance ratings) to support data-driven HR strategies.
• Ensures all employee records and employment documents are maintained in compliance with legal and company standards.
• Supports annual salary review, bonus, and incentive processes in coordination with the global HR team.
• Contributes to continuous improvement of HR operational processes and employee experience.

Requirements:

• 5 + years' experience in human resources management within the pharmaceutical industry is required;
• Previous experience in recruitment, talent development, and employee relations a plus;
• In-depth knowledge of legal requirements related to human resources including workers’ compensation, union relations, and federal and state employment laws;
• Excellent communication and interpersonal skills.

We are seeking a dynamic individual to manage the day-to-day operations in a Biotech environment. This is an exciting and unique opportunity to support our Pharmaceutical Development team’s office and lab space. The successful candidate will be able to thrive in a fast-paced, ever-changing environment, and manage competing priorities, while maintaining a professional demeanor with employees.

In this critical role, you will serve as the primary interface between our company and its service providers, vendors, and consultants. This position requires great attention to detail, organization, and professionalism, and the ability to maintain an efficient business environment.

Responsibilities, including but not limited to:

·Ensure smooth daily operations of the office environment, making sure employees have a clean and safe office.

·Greet and check in visitors and vendors as required, directing them to the appropriate person as needed.

·Troubleshoot any office issues and escalate to the appropriate teams as needed.

·Coordinate with the Facilities team to manage all ongoing facilities-related issues, including maintenance requests submitted by employees, cleanliness of the office space, as well as landlord relations.

·Manage facility service coordination: office supplies, vendors, non-lab equipment, space planning, and office expansion efforts.

·Develop and manage relationships with catering sites for weekly lunches and events.

·Maintain an effective file organization for administrative projects and office files that are accessible to the team if needed.

·Ensure office and operations security by maintaining the security access database, file keys, access cards, and office keys

·Provide human resources support and miscellaneous administrative project support as necessary, ex: monitoring on boarding of new employees to ensure a positive employee experience

·Sort and distribute incoming mail to the appropriate recipients

·Event planning as needed.

Qualifications:

·Bachelor's degree Preferred

·At least 2-4 years’ experience in a life sciences environment preferred

· Proficiency in Windows operating systems, Outlook, Word, Excel, and general office equipment

· Ability to multitask with several priorities and maintain a high standard of discretion and confidentiality

·Excellent communication and interpersonal skills

· Flexible, confident, and driven toward results

• · Ability to work with minimal supervision