Quality Assurance Specialist II

Planet Pharma; Philadelphia (Philadelphia County); On-site; Full time

Job summary

An established industry player in pharmaceutical manufacturing is seeking a Quality Assurance Specialist II to ensure compliance with quality and regulatory standards. This exciting role involves supporting the quality assurance operations for commercial and clinical products, working closely with contract manufacturing organizations. The ideal candidate will have a strong background in biopharmaceuticals, excellent communication skills, and a knack for problem-solving. Join a dynamic team where your contributions will directly impact the success of innovative healthcare solutions. If you're ready to take on new challenges in a fast-paced environment, this opportunity is for you!

Qualifications

• 2+ years of biopharmaceutical industry experience required.
• Strong knowledge of GMPs and health authority standards.

Responsibilities

• Support quality and regulatory compliance for products.
• Review and approve batch records and SOPs for compliance.

Skills

Aseptic gowning

GMP knowledge

Problem-solving

Collaboration

Communication skills

Ability to multi-task

Education

BA/BS in life sciences

Tools

Microsoft Office Suite

Job description

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

$40.00/hr - $45.00/hr

CONTRACT-TO-HIRE

MUST HAVES:

• BA/BS degree in life sciences discipline or equivalent
• 2+ years of biopharmaceutical industry experience or similar regulated environment
• Good Aseptic gowning background/experience
• Manufacturing/GMP experience

Overview

The Quality Assurance Specialist II will report to the Director, Quality Assurance Operations. The position will support the quality and regulatory compliance of commercial and clinical products including manufacturing, testing, and release at contract service providers. Further, the position will be responsible for ensuring that these operational activities are maintained in accordance with GMPs, global health authorities’ requirements and expectations.

Shift:

• Wednesday to Saturday from 7:00 AM - 6:00 PM. (4 days - 10 Hours Shift)

Essential Functions and Responsibilities

• Represent QA by working on-site at the CMO for up to 5 days per week.
• Support CMO manufacturing, testing, and release activities on weekends, as needed.
• Establish and maintain direct lines of communication with the CMO QA functions.
• Review/approve master/executed batch records for manufacturing, testing of raw materials and finished products. Participate in the review of investigations and deviations.
• Release/reject clinical lots and issue appropriate release certificates. Maintain batch record files and associated documentation.
• Develop, or review, Standard Operating Procedures (SOPs) required for supporting system changes/enhancements to ensure compliance with Good Manufacturing Practices (GMPs) requirements.
• Support/Represent Quality in creation, presentation of Quality management review metrics as necessary.
• Interface and support management of CMOs as needed.
• Support other quality systems/operations activities as requested.
• Support in regulatory inspection and inspection readiness activities.
• Other duties as assigned.

Required Education and Qualifications

• BA/BS degree in life sciences discipline or equivalent.
• 3+ years of biopharmaceutical industry experience.
• Direct experience with review of clinical manufacturing documentation and release of clinical products. Cell therapy experience is a plus.
• Strong working knowledge of GMPs and Health Authority standards and expectations in both the US and Europe.
• Ability to follow through on all activities to ensure projects are completed as planned.
• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.
• Demonstrated ability to collaborate and influence across organization to gain support and commitment for team goals.
• Strong professional interpersonal and communications skills, both verbal and written to provide clear direction for the business, vendors, internal stakeholders.
• Ability to meet deadlines and multi-task efficiently; must be willing to work a flex schedule.
• Proficient with the Microsoft Office Suite, Word, Excel, PowerPoint and Project.

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

Physical Demands and Activities Required:

• Must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
• Able to stand and/or walk 90% (and sit 10%) of the scheduled workday, which may include climbing ladders or steps.
• Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Must be able to lift and carry objects weighing 45 pounds.

Mental:

• Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to manage multiple priorities simultaneously; and ability to meet deadlines.
• This position will work in both an office and a manufacturing lab setting.
• When in the lab, must be able to work in a Lab setting with various chemical/biochemical exposures, including latex and bleach.
• Able to work in a cleanroom with biohazards, human blood components, and chemicals.
• Potential exposure to noise and equipment hazards and strong odors.

Seniority level

Associate

Employment type

Full-time

Job function

Research and Science

Industries

Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing