Planet Pharma Remote Jobs in Usa

Duties:

Animal Care Technician

Performs animal husbandry and health care in accordance with experimental protocol and Animal Welfare Act/Regulations, NIH Guide for the Care and Use of Laboratory Animals, Guide for the Care and use of Agricultural Animals in Research and Teaching, Veterinary Sciences standard operating procedures, and the fundamental requirements for AAALAC accreditation. In addition, this individual assists with scientific procedures in accordance with study protocols, completes and maintains appropriate documentation associated with all job assignments, and provides equipment sanitation and facility maintenance. This individual will work in an animal research laboratory setting under Biosafety conditions.

Duties & Responsibilities:

• Complies with applicable regulations and company policies. Documents and maintains records of animal care, preventive medicine, USDA-required, and study protocol-driven documents. Provides animal husbandry and care including provision of feed, water, and enrichment materials. Maintains, adjusts, and repairs animal pens, feeders, drinking systems, and livestock handling equipment. Performs cleaning and sanitation of animal rooms and equipment.
• Recognizes when animals are sick, distressed or otherwise abnormal and communicates these observations to the Site Veterinarian or Group/Team Leader. Conducts daily animal health and welfare assessments.
• Conducts scientific clinical observations and assessments.
• May perform site biosecurity functions including water system sanitation, bagged feed and fomite decontamination, and environmental auditing sample collection.
• Assists with clinical R&D sample collection in accordance with study protocols and direction of Investigator or delegate

Skills:

Requirements:

• This position requires a High School diploma or equivalent degree (GED) and a minimum of two (2) years experience in a related field. Such fields may include livestock handling, husbandry, and healthcare, veterinary clinical assistance, and/or scientific animal research. This related experience may be obtained concurrent with the diploma/degree.
• This person should either already possess or be willing to obtain Assistant Laboratory Animal Technician (ALAT) certification, preferably within 12 months of employment. Certification timelines will be dependent upon prior education and experience.

Physical and Mental Requirements to Perform Essential Functions:

1. Physical Demands / Surroundings - This position requires the ability to work in inclement environments (hot, cold, noisy, humid, etc.) with a high priority focused on biosecurity, attention to detail, and timeliness. Individual must demonstrate persistence and energy in a dynamic, fast-paced, and demanding work environment. Some heavy lifting is required and must be able to lift up to 70 pounds occasionally and up to 50 pounds frequently. Travel outside of local area is rarely required. Must be willing to work directly with animals. This person must not have allergies to animals or livestock/feed dust.
2. Visual Demands – Must be able to read and see clearly. Prescription eye wear is allowed.
3. Temperament / Mental Requirements - Must be able to maintain even temperament when working with all animals. Position requires willingness to learn at a rapid pace. Individual must be results oriented, cooperative, and a systematic thinker. Must be able to work in a multi-disciplinary matrix environment and value the importance of teamwork. Must exhibit sound judgment and analytical thinking. This person must demonstrate ability to manage processes, projects, and to function well in a team or committee role.
4. Other Proficiencies – Must possess effective verbal and written communication skills in English, sufficient for accurate transmission of information internally. Requires ability to interface and build working relationships with team members at all levels of site organization. Must be proficient in basic computing skills such as e-mail communication and word processing.
5. Attendance / Schedule – Attendance requirements are based upon BI AH general attendance policies. Must have reliable transportation and must be able to work weekends.
6. These physical and mental requirements represent a sampling of those considered essential to this position. Although this is an accurate representation, it is by no means complete and may be changed or updated as needed.

Must conduct business in such a manner as to comply with all regulations and policies governing animal care and welfare, scientific procedure, hazardous material, and biological agent containment as set forth by the USDA, EPA, The Guides, management, and other regulatory and accrediting agencies.

Job Summary:

As a Customer Relationship Specialist you will be responsible for the success of our customers. This demanding role requires a unique skillset. Working with a sales professional, you will assist in preparing sale intake documents, setting up accounts, placing orders, and answering customer inquiries in an efficient and professional manner. You will act as an advocate for our customers and a champion for our brand. Your job ensures our customers have the best experience possible.

Responsibilities/Essential Duties:

• Act as a liaison by managing both incoming and outgoing calls, emails or live chat support.

• Ensure the best experience possible, no matter what channel our customers choose to contact us.

• Work alongside sales professionals to deliver a high-end customer experience.

• Take ownership of account interactions from beginning to end.

• Complete thoughtful, personalized responses to a variety of customer request such as:

• General Inquires

• Account Creation

• Pricing

• Product Orders/Returns

• Billing Inquiries

• Payments

• Upselling and Cross selling - Great starting point from which to grow toward a sales career.

• Contribute to the ongoing success of your team by achieving goals and objectives .

Inbound Call Requests Include:

Onboarding

Revenue Orders

Sample Orders

Billing Inquiry

Shipping/Tracking

Account Password Reset

Invoices

Account Set-up

Performance Metrics (KPIs):

Average Handle Time (AHT)

Customer Satisfaction

Quality Monitoring of Calls

Basic Qualifications:

• Associate/Bachelor’s degree, or equivalent work experience.

• REQUIRED: 5 years’ experience in a call center/inside sales role.

• The ability to exercise initiative.

• Strong communication skills: oral, written and interpersonal.

• Proficiency in Microsoft Office applications: Word, Excel, PowerPoint, SharePoint and OneNote.

Preferred Qualifications:

• Knowledge of customer service principles and practices.

• A strong understanding of telephony and technology, and not be intimidated by it.

• The ideal candidate must be comfortable working in a fast-paced environment.

Lab Assistant – Dover, DE

Contract: 3 months, contract-to-hire

Pay Rate: $24–$26/hr. DOE

Must-Have Skills: LC-MS, GC-MS, and sample preparation

Job Description Summary

The Instrument Readiness Specialist provides operational and technical support for LC-MS, HPLC, and GC-MS laboratories at Customer facilities in Delaware. This role includes routine instrument operation, sample preparation support, preventive maintenance, performance monitoring, and compliant documentation following Customer SOPs, validated methods, and regulatory requirements.

The position requires strong attention to detail, the ability to work independently in a laboratory environment, and effective collaboration with Customer scientists and project stakeholders to ensure reliable analytical operations.

Job Responsibilities

• Provide hands-on operational support for LC-MS, HPLC, and GC-MS instrumentation at Customer facilities, including the DuPont Experimental Station (Wilmington, DE) and New Castle, DE, following SOPs, validated methods, and compliance requirements.
• Perform routine operation of analytical systems: instrument startup/shutdown, method loading, sequence/sample queue setup, data acquisition, and basic system checks.
• Support sample preparation activities: dilution, extraction, filtration, derivatization (as applicable), reagent preparation, consumable selection, and proper sample labeling per Customer-approved procedures.
• Monitor and assess instrument performance: chromatographic stability, pressure/flow profiles, vacuum system performance, detector response, ion source condition, mass accuracy, and column integrity; promptly communicate deviations or abnormal trends.
• Conduct routine preventive maintenance and system upkeep: solvent/mobile phase preparation, degassing, tubing/fitting inspection, leak checks, column flushing, injector/ion source cleaning, vacuum pump monitoring, tuning verification, and routine calibration per manufacturer and Customer requirements.
• Support day-to-day lab operations: equipment readiness, workflow coordination, and effective communication with project leads and local stakeholders.
• Comply with all site-specific safety, laboratory access, emergency response, and environmental health requirements; participate in required safety, EHS, and instrumentation training programs.
• Maintain accurate documentation of instrument usage, maintenance activities, experimental observations, deviations, and corrective actions per Customer practices and data integrity standards.
• Prepare analytical summaries, instrument performance logs, and status updates as requested.
• Ensure proper archiving of raw data, chromatographic results, mass spectral files, electronic logs, and supporting documentation within Customer systems.
• Document and escalate deviations, nonconformances, or unexpected findings promptly; support quality assurance, audit readiness, and inspection activities as requested.

Note: Management reserves the right to assign or reassign duties at any time.

Critical Skills

• Working knowledge of LC-MS, HPLC, and GC-MS instrumentation and laboratory workflows
• Ability to operate analytical instruments according to SOPs, validated methods, and compliance requirements
• Strong attention to detail and commitment to data integrity
• Ability to monitor instrument performance, identify deviations, and escalate issues
• Hands-on experience with routine instrument maintenance, troubleshooting, and preventive care
• Strong organizational and time-management skills in a fast-paced laboratory environment
• Ability to follow instructions and adhere to established procedures
• Effective communication and collaboration with scientists, vendors, and site stakeholders
• Ability to work independently while supporting team objectives

Basic Qualifications

One of the following education and experience combinations:

• Bachelor’s degree in chemistry, biology, biochemistry, or related discipline + 3+ years of relevant lab experience supporting analytical instrumentation
• Associate’s degree in a scientific/technical discipline + 5+ years of hands-on experience supporting LC-MS, HPLC, or GC-MS systems
• High School diploma or GED + 7+ years of directly related laboratory experience in an analytical environment

Additional Requirements:

• Basic proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint)

Preferred Qualifications

• 5+ years supporting LC-MS, HPLC, and/or GC-MS in industrial, academic, or regulated labs
• Master’s degree in chemistry, analytical science, or related discipline
• Experience in SOP-driven or regulated labs (GLP, GMP, or similar)
• Familiarity with analytical data systems, ELNs, and data archiving
• Demonstrated ability to support audits, inspections, or QA activities

Working Environment

• Work in laboratory and controlled environments requiring PPE (lab coat, safety glasses, etc.)
• Fast-paced environment with high job completion demands
• Stationary work >25% of the time; occasional movement between labs, corridors, adjoining rooms, and buildings
• Frequent bending, squatting, stretching, and reaching for instrument operation
• Occasionally lift/move up to 25 pounds (potential up to 50 pounds)
• Vision requirements: close-range observation, color vision, peripheral vision, depth perception, ability to adjust focus
• Occasional use of computers and office machinery
• May handle hazardous waste per regulations
• Exposure to lab hazards: extreme temperatures, biological materials, hazardous chemicals
• May require medical clearance, respiratory protection training, and respirator fit testing

Responsible for the dispensing of raw materials liquids and powders (hazardous and non-hazardous), acids/bases, under cGMP conditions to support the manufacture of therapeutic proteins (API)

Individual will be required to perform and monitor all dispensing processes and weighs, including liquid, powder (hazardous and non-hazardous), acids and bases. All processes will be completed per cGMP guidelines to support the manufacture of therapeutic proteins (API).

• Required to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique and cross contamination awareness in handling of products and materials.

• Expected to follow and adhere to all written procedures (SOPs), monitor equipment and processes, perform basic laboratory tasks, including pH, conductivity, and sampling as required. All tasks will be completed while gowned and wearing required PPE while working in a Class C environment.

• Expected to execute process recipes.

• Ability to qualify for all assigned tasks and maintain individual training plan.

• Ability to qualify and perform required functions and scheduled cleans on all Dispensing equipment through routine cleaning and sanitization.

• Perform peer, First Level Reviews of completed eDispense orders/kits, upon completion of WBT and LQM/PM signoff by area trainer.

• Ability to report to production via written and electronic documents in accordance with current good manufacturing practice (cGMP) and good documentation practice (GDPs). Complete documentation reviews as appropriate.

• Prepare materials for transport and delivery to manufacturing suites. Perform material movements both physically and in software systems.

• Participate in Safety Inspections and submit safety observations to provide safer working conditions for self and others.

• Administrative tasks to include attendance at shift exchange and required meetings, sending/receiving of emails, and participation in assigned projects.

• Performs other duties as they are assigned to support Logistics Team.

Associates Degree and/or equivalent experience

Job Summary

The Analytical Operations (AO) department is seeking an enthusiastic and motivated Research Associate to be part of our analytical testing team. This role utilizes analytical tools to characterize the physical and chemical properties of biopharmaceutical products. This work is essential for supporting both process development and validation, and for determining product quality, purity, and stability.

About Analytical Operations (AO)

Analytical Operations (AO) is a non-GMP department within the PTDA Analytical Development Quality Control organization, dedicated to advancing the company's R&D pipeline. The department is focused on providing technical expertise and analytical support for early-stage research, development, and process validation for departments across the South San Francisco campus as well as other internal sites. This support is delivered through high-throughput testing, automation, effective data management, and robust business processes, all of which facilitate timely and scientifically informed decisions.

Key Responsibilities

• Conduct routine and non-routine analytical testing using a variety of physiochemical techniques (U/HPLC, icIEF, CE-SDS, and LC-MS), according to established protocols.
• Maintain accurate, detailed documentation of assays and data results in an Electronic Laboratory Notebook (ELN), strictly adhering to ALCOA+ principles.
• Perform essential lab support tasks, including stocking consumables, checking for expired reagents and hazardous waste, and de-icing freezers.
• Comply with laboratory best practices, safety guidelines, and internal and regulatory standards.

Job Requirements

• Bachelors degree with a minimum of 3 years of relevant experience, or a Masters degree with laboratory experience in Chemistry, Biochemistry, or a related scientific field. Experience in the biotech or pharmaceutical industry is preferred.
• Must be highly organized, detail-oriented, and self-motivated, with a proven ability to successfully manage multiple tasks, both independently and collaboratively as part of a team
• Hands-on experience with HPLC/UPLC, CE, or LC-MS is required.
• Strong written and verbal communication skills are a must, with the ability to present technical work clearly.
• Knowledge of GMP compliance, experience with ELN, and intermediate proficiency in Microsoft Excel is highly desirable.
• Ability to lift 20 lbs. for laboratory-related tasks.

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.

Executive Assistant to VP Global Supply Chain

We are seeking an exceptional Executive Assistant to support the VP of Global Supply Chain. This opportunity requires a polished professional who thrives in a fast-paced, dynamic environment and is motivated by the opportunity to impact across the organization.

More than an administrative partner, the Executive Assistant will serve as a trusted extension of the VP of Global Supply Chain. anticipating needs, taking initiative, and creating leverage so the VP Global Supply Chain can focus on the most critical priorities. In addition, this role provides the opportunity to influence and support other administrative staff, encouraging teamwork, fostering collaboration and building a collegial, collaborative environment. This position is highly cross functional and global in scope, requiring the ability to navigate multiple time zones, cultures and priorities.

What You’ll Do

• Serve as the right-hand; anticipating needs, taking initiative, and creating leverage so the VP Global Supply Chain can focus on critical priorities.

• Orchestrate complex scheduling, travel, communications, and team preparation with discretion, accuracy, and efficiency.

• Serve as a trusted liaison for the VP Global Supply Chain with senior leaders and external partners – ensuring seamless preparation and execution of meetings while representing the company with professionalism, poise and executive presence.

• Partner in building and sustaining company culture by supporting offsites, events, and initiatives that strengthen engagement across BioMarin's global sites.

• Support the VP Global Supply Chain and fellow administrative professionals in leveraging digital tools—including emerging technologies like AI—to drive efficiency and unlock new ways of working.

• Draft, review, and refine communications, presentations, and reports with clarity, accuracy, and professional polish.

What You Bring

• 10+ years of experience supporting senior executives in complex, global, or high-growth organizations.

• A reputation for being proactive, kind, and highly attuned to anticipating the needs of executives.

• Demonstrated success managing interactions with senior leadership teams.

• Exceptional organizational skills with the ability to manage multiple, shifting priorities in high-pressure environments.

• Superior written and verbal communication skills, with executive-level polish.

• Strong problem-solving ability and creativity in approaching challenges.

• Experience mentoring or leading administrative professionals.

• Proven fluency with modern digital tools and platforms; comfort guiding others in navigating emerging technologies.

Work Hours/Location: This is a full time, hybrid onsite role based at HQ in San Rafael, CA. You will typically work onsite most days alongside other Executive Assistants.

Why Join Us?

This is a unique opportunity to directly support the VP Global Supply Chain of a global biotechnology leader, helping drive organizational impact and supporting the mission to bring life-changing therapies to patients around the world. In this role, you will contribute to the growth and culture of the company, and gain exposure to strategic decision-making at the highest levels. You’ll collaborate with talented colleagues worldwide and play a critical role in enabling the future of an innovative, mission-driven organization.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Requirements: Delaware Journeyman Electrician license and strong hands-on experience in a manufacturing environment

Pay Rate: $40–$45/hour

Shift: Rotating shifts — 6:00 AM–2:00 PM and 2:00 PM–10:00 PM

General Functions & Scope

Primary responsibilities include troubleshooting, repairing, and maintaining high-speed production and packaging equipment, serving as a technical resource for electrical motors, drives, and major components. This role requires working knowledge of the practices, tools, equipment, and materials used within the mechanical trades, along with hands-on experience repairing and troubleshooting production equipment. Strong evaluation skills, originality, and ingenuity are essential.

Key Accountabilities

• Ensures operation of machinery and mechanical equipment by completing preventive maintenance on engines, motors, pneumatic tools, conveyor systems, and production machines. This includes following diagrams, sketches, operations manuals, manufacturer instructions, and engineering specifications, as well as troubleshooting malfunctions.
• Locates sources of problems by observing mechanical and electrical devices in operation, listening for irregularities, and using precision measuring and testing instruments.
• Removes defective parts by dismantling devices using hoists, cranes, and hand and power tools, and examines the form and condition of parts.
• Determines dimensional changes in parts by inspecting used components and utilizing measurement tools such as rules, calipers, micrometers, and other precision instruments.
• Adjusts functional parts of devices and control instruments using hand tools, levels, plumb bobs, and straightedges.
• Controls downtime by informing production workers of routine preventive maintenance techniques and monitoring compliance.
• Fabricates repair parts using machine shop instrumentation and equipment.
• Maintains equipment, parts, and supplies inventories by checking stock levels, anticipating needs, and generating purchase requisitions.
• Conserves maintenance resources by using equipment and supplies efficiently.
• Provides mechanical and electrical maintenance information and prepares maintenance reports by collecting, analyzing, and summarizing information and trends.
• Maintains technical knowledge through educational workshops, technical publications, and professional networks.
• Maintains continuity among work teams by documenting and communicating actions, irregularities, and ongoing needs.
• Maintains a safe and clean working environment by complying with procedures, rules, and regulations.

Qualifications / Competencies

Electrical Journeyman’s Papers are required, with the ability and desire to attain Master Electrician Papers. Key competencies include equipment maintenance, technical understanding, adaptability in uncertain environments, electrical safety knowledge, proficiency with power tools, attention to detail, flexibility, supervision, job knowledge, and productivity.

Physical Demands

While performing job duties, the employee may be required to stand, walk, sit, use hands to handle or feel objects, reach with hands and arms, climb stairs, balance, stoop, kneel, crouch, crawl, talk, and hear. The role requires occasional lifting and moving of up to 50 pounds. Vision requirements include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.

Work Environment

The employee works in a standard manufacturing environment with a moderate noise level. Occasionally, duties may be performed in hot, dusty, or cramped areas. Additional personal protective equipment may be required.

Working Hours

This is a full-time position requiring shift work, including days, nights, weekends, and occasional holidays. Some flexibility in hours is allowed; however, availability during scheduled shifts is required. Shift hours are established by department managers or supervisors.

Job Summary

We are seeking a detail-oriented Quality & Regulatory Specialist to support compliance, quality management, and regulatory activities. This role ensures adherence to international regulations and standards, supports product registrations, and maintains the company’s Quality Management System (QMS). This position requires strong knowledge of medical device regulations (e.g., FDA, EU MDR, ISO 13485) and excellent cross-functional collaboration.

Essential Duties and Responsibilities

• Regulatory Affairs
• Lead preparation, submission, and maintenance of global regulatory filings (FDA 510(k)/PMA, EU MDR Health Canada and other international registrations).
• Serve as primary contact with regulatory authorities, notified bodies, and certification agencies.
• Interpret evolving regulatory requirements and communicate strategic implications to leadership.
• Provide regulatory input on new product development, product changes, labeling, and marketing materials.
• Monitor regulatory changes and advise internal teams on impact to product development and market access.
• Quality Management System (QMS)
• Maintain and improve the QMS in compliance with ISO 13485, 21 CFR Part 820, and applicable standards.
• Support internal and external audits, inspections, and corrective actions.
• Ensure document control, training, and change management processes are properly implemented.
• Product Lifecycle Support
• Partner with R&D, manufacturing, and clinical teams to ensure design control, risk management, and post-market surveillance compliance.
• Review and approve quality/regulatory aspects of labeling, promotional materials, and product changes.
• Support vigilance reporting, complaint handling, and CAPA activities.
• Cross-Functional Collaboration
• Provide regulatory and quality guidance during new product development.
• Liaise with regulatory authorities, notified bodies, and certification agencies.
• Train employees on regulatory and quality compliance topics.
• Perform other duties as assigned by manager or supervisor

Experience & Education Requirements

• Bachelor’s degree in engineering, life sciences, regulatory affairs, or related field or equivalent work experience in those areas.
• 5-8 years of experience in quality and/or regulatory affairs in the medical device industry.
• Strong knowledge of ISO 13485, ISO 14971, 21 CFR Part 11/820, EU MDR 2017/745.
• Experience with regulatory submissions (FDA, EU, or other international markets).
• Excellent analytical, organizational, and communication skills.

Preferred Skills & Abilities

• Medical device industry experience
• Medical Device regulation requirements knowledge, as applicable to responsibilities
• Regulatory Affairs / Quality Assurance Certification (e.g., RAC, CQE, CQA) is a plus.

625870

Our client, a leading Medical Device company located in Irvine, CA, is looking for a Engineering Project Manager III to plan, direct, and coordinate project activities with ownership for successful completion of all project deliverables to the business within established schedule, scope, financial and quality objectives. Projects will be for their Technical Service organization including launching service capabilities on new electronic products to their global service centers. The role will be onsite.

Required Skills:

• Degree in engineering, science or related
• Regulated manufacturing environment experience
• Experience with regulatory agency guidelines for medical device manufacturers is highly preferred.
• Project Management Professional (PMP) Certification is preferred.
• Proven track record in the management of multiple complex, large-scale projects with the ability to prioritize projects.
• Advanced skills in using and creating schedules in Microsoft Project.

Responsibilities:

• Manage project initiation/planning, execution, controlling, and closing phases.
• Manage large scale to enterprise-wide projects within program.
• Create and manage project schedule and action item trackers.
• Develop a high-level milestone plan for the program and manages program change in accordance with the change management plan to control scope, mitigate risks, quality, schedule, cost, and contracts.
• Establish and maintain program stakeholder relationships, expectations, and communications, both internal and external to the organization.
• Manage and control changes from original scope for every project.
• Serve as conduit between project/team members in all cross-functional groups.
• Perform other duties and responsibilities as assigned.

***Compensation within this range will be commensurate with level of experience***

The position of Technical Manufacturing Chemist is within the Infectious Disease (ID) business unit located at Scarborough, Maine. In this role you will produce material for use in immunology-based chromatography and enzyme tests.

(This job description is reviewed periodically and is subject to change by management.)

RESPONSIBILITIES:

• Maintains and supports the production schedule

• Investigates problem areas and areas of desirable improvement

• Undertakes new procedures and observes proper safety precautions

• Responsible for in-process QC testing of manufacturing material as it relates to

qualifications, quality inspections and titration.

• Maintains quality systems and proper GMP/GLP

• Creates and follows protocols designed around product improvement

• Responsible for making critical and non-critical bioreagents for use in product and manufacturing processes using Standard Operating Procedures (SOPs).

• Works in a team setting and coordinates manufacturing efforts based upon a set

production schedule and maintaining the raw bioreagent supply as needed to support this schedule.

BASIC QUALIFICATIONS | EDUCATION:

• Bachelors Degree in a Chemistry, Life Sciences, or related field or equivalent

combination of education and experience.

• Prior Experience in the following areas:

o Pipette

o Spectrophotometry

o HPLC

o pH meters

o Gel Electrophoresis o SDS Page

o ELISA assays

COMPETENCIES:

• Ability to work successfully as a member of a team and independently with moderate supervision.

• Skill in using computer applications including spreadsheet, database, manufacturing, and word processing software Provides reasonable accommodation to qualified individuals with disabilities.

The Inspector performs basic routine inspection of electronic, electro-mechanical and/or mechanical materials, components and sub-assemblies received, in process of manufacture, or manufactured, for conformance with quality assurance standards.

Key Job Duties and Responsibilities:

Inspection & Testing: Performs visual and physical inspections of raw materials, in-process components, and finished products to ensure they meet quality specifications. Uses precision measuring tools and lab equipment to verify product dimensions and performance.

Documentation & Compliance: Accurately maintains Lot History Records (LHR), batch records, and inspection logs in compliance with Good Documentation Practices (GDP) and FDA regulations.

Defect Management: Identifies, classifies, and reports defects. Manages non-conforming material by initiating Non-Conformance Reports (NCR) and assisting with investigations.

Process Control: Monitors production processes to ensure adherence to standard operating procedures (SOPs) and Good Manufacturing Practices (GMPs).

Equipment Maintenance: Calibrates, cleans, and performs routine maintenance on inspection and testing equipment to ensure accuracy.

Collaboration: Works with production and engineering teams to support quality improvements, provide feedback on product quality, and ensure regulatory compliance.

Key Competencies:

Attention to Detail: High level of accuracy in documentation and inspection.

Computer Literacy: Proficient in using software like SAP, POMS, or Laboratory Information Management Systems (LIMS).

Technical Knowledge: Understanding of ISO 13485 and FDA 21 CFR Part 820 regulations.

Communication: Ability to clearly report deviations and collaborate in a team environment.

Common Educational/Experience Requirements:

High school diploma or equivalent is required. Associates or Bachelors degree in a technical field preferred.

Previous experience in manufacturing, particularly in medical device, pharmaceutical, or similar regulated industries is highly desired. 1+ years of experience desired.

The Manager Quality Systems is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, cosmetics, combination products and biologics.

This role will support the strategic direction to ensure business objectives are met.

Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training, Quality Intelligence, This position will also translate strategy into tactical objectives to deliver strategic plans and regulatory updates.

This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.

Studies the basic principles of plant life and the effects of varying environmental and physical conditions. Familiar with standard concepts, practices, and procedures within a particular field. Relies on limited experience and judgment to plan and accomplish goals. Performs a variety of tasks. Works under general supervision; typically reports to a supervisor or manager. A certain degree of creativity and latitude is required.

Will be working with row crops (canola, corn, cotton, and soybeans) in greenhouses and growth chamber settings. Duties will vary from day to day, but will include sowing, plant care, discarding, cleaning, transplanting, harvesting, and seed processing. Position requires standing for long periods of time. Detail orientation is required due to nature of work. Elevated temperatures will occur in greenhouses in warmer months. Rotational weekend work may be required.

Qualifications - Experience in controlled environment and growing plants is preferred. Commercial greenhouse experience would qualify.

Education - Associates or Bachelors degree in agronomy, biology, horticulture, or other life sciences.