Quality Assurance Training Specialist

Planet Pharma; Philadelphia (Philadelphia County); On-site; USD 80,000 - 86,000; Full time

Job summary

Join a dynamic team at a leading pharmaceutical firm where your expertise in training and quality assurance will shine. This role offers the chance to develop and maintain training materials, ensuring compliance with Good Manufacturing Practices (GMP). You will collaborate with various teams to enhance training efficiency and support documentation needs. Embrace an opportunity to work in a vibrant office and lab environment, contributing to impactful projects that uphold the highest standards in pharmaceutical manufacturing. If you are detail-oriented and passionate about quality assurance, this role is perfect for you.

Benefits

Vision insurance

Medical insurance

401(k)

Annual Bonus

Stock options

Qualifications

• 2+ years experience in training and documentation in GMP environments.
• Familiar with FDA quality systems and document change management.

Responsibilities

• Assist in developing and reviewing training materials.
• Administer training in eLMS and provide user support.
• Collaborate on training requirements impacting quality processes.

Skills

Attention to Detail

Communication Skills

Organizational Skills

Problem-Solving

GMP Knowledge

Document Change Management

Training Experience

Education

Bachelor’s degree in Life Sciences

Tools

eDMS (MasterControl preferred)

Microsoft Word

Microsoft Excel

Job description

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This range is provided by Planet Pharma. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$80,000.00/yr - $86,000.00/yr

Additional compensation types

Annual Bonus and Stock options

Shift: Wednesday to Saturday 7am to 6pm

Essential Functions and Responsibilities

• Assist in the development and/or review developed training materials.
• Maintain qualification training requirements in eLMS.
• Administer and assign training in eLMS
• Provide eDMS/eLMS End User Support
• Collaborate with Quality Assurance Document Control on training requirements impacting Document Change Control process.
• Supports training implementation in response to quality events
• Deliver training sessions, when applicable, and ensure training documentation is maintained. Ensure training schedules meet company production and quality targets.
• Assists functional groups with the creation or improvement of training content
• Continuously seek and support new approaches, practices and processes to improve the efficiency and efficacy of training.
• Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
• Supports documentation needs, which may include drafting and approval of SOPs, Work Instructions, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.
• Attends meetings and escalates issues/concerns at that forum to Area Management for further investigation.
• May work on assignments that are moderately complex in nature, where judgment is required to resolve operational issues without negatively impacting manufacturing efforts.
• Ability to work in a team environment and independently as required.
• Contribute to department operations improvement in areas such as SOP revisions and department inspections.
• Other duties as assigned.

Required Education, Skills, and Knowledge

• Bachelor’s degree in Life Sciences discipline preferred, not required.
• Minimum of two (2) years of experience training and documentation in pharmaceutical or biopharmaceutical GMP based facility.
• Familiar with document change management and FDA quality systems
• Familiar with an eDMS system (MasterControl is a plus)
• Must possess a high level of attention to detail and proficient in Word and Excel
• Strong computer, organizational, and compliance skills
• Ability to work effectively on multiple projects simultaneously with minimum supervision.
• Strong interpersonal and communication skills

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

This job works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical is possible. Requires operating standard office equipment and keyboards.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance, Science, and Manufacturing

• Industries

  Pharmaceutical Manufacturing, Biotechnology Research, and Research Services

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Inferred from the description for this job

Vision insurance

Medical insurance

401(k)

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