QA, Analyst III (Biopharma)

THIS ROLE WILL REQUIRE RELOCATION To The Baltimore, MD Metro Area

This Permanent Full-Time Position offers unique working culture and an exceptionally competitive compensation package.

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Biopharma Quality Assurance, Analyst III,

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Our team at PharmAllies has teamed up with a mid-sized biopharma manufacturing firm to supply them with the personnel (Full-Time Permanent Positions) needed for critical COVID vaccine manufacturing efforts. At the forefront of producing lifesaving vaccines, this company values the diversity each employee brings to their role and their contributions to helping them achieve their mission to protect and enhance life. They also value talent, develop employees and offer opportunities to advance their staff to achieve personal and professional growth. So, if you want to make a worldwide health impact, look at our available positions and apply today!

JOB SUMMARY

The QA Analyst III is responsible for assisting and supporting preparation, testing, and monitoring of conformance to established quality assurance processes and standards for manufacturing and production. They identify risk and evaluate deficiencies while working with internal departments to appropriately remedy them. They facilitate internal training on quality assurance requirements, processes, and procedures. May perform audits and risk assessments.

ESSENTIAL FUNCTIONS
Reasonable accommodations will enable individuals with disabilities to perform the essential functions.

· Critically review and approve various types of documentation to ensure completeness, accuracy, and compliance including, but not limited to, manufacturing records and Quality Control laboratory data for batch and material releases, specifications, SOPs, validation protocols and summary reports, master plans, deviation investigations, CAPAs, and change controls.

· Exercises good judgment within defined procedures to determine appropriate action for resolution of manufacturing or laboratory issues

· Serves in a decision-making capacity on major document changes, deviations, corrective and preventive actions, change control, and other projects

· Performs in-process audits of manufacturing facilities and processes, including aseptic processes and behavior.

· Reviews routine work orders, return-to services, and other documents to ensure that equipment and utilities are fit for use.

· Network with senior internal and external personnel in own area of expertise.

· Communicates effectively with management project status, issues, and mitigations.

· Assumes responsibilities for assigned tasks including a subset of the activities listed herein.

· Participates in batch release and all quality systems associated with batch release:

· Review of manufacturing and testing records to ensure compliance to site procedures, regulatory requirements, and product license requirements.

· Review deviation investigations, including root cause analysis.

· Supports the development and execution of CAPA plans to address identified deviation root causes or compliance/quality gaps.

· Coordinates and supports the development and execution of change control plans to ensure compliant implementation of product and/or process changes.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

· BA/BS (preferably in an Applied Science) or equivalent work experience

· 3-5 years of CGMP experience

· Prior experience with US and EU pharmaceutical regulations, ISO standards

· Knowledge and application of CGMP principles and working in FDA-regulated environment.

· Critical analytical skills and strong verbal and communication skills

· Ability to work under pressure and analyze processes within scheduled timeframes

· Ability to work independently and in a team setting with minimal supervision.

· Ability to make sound decisions regarding compliance-related issues with minimal supervision. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

*Requires vaccination against different viruses including Vaccinia virus.

Job Type: Full-time

Pay: From $1.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Parental leave
• Vision insurance

Schedule:

• 8 hour shift

Supplemental Pay:

• Bonus pay

Application Question(s):

• Will you now, or in the future require our company to commence (sponsor) an immigration case in order to employ you (for example, H-1B or other employment-based immigration case)?
• Are you willing to relocate to Maryland?

Education:

• Associate (Preferred)

Experience:

• ISO standards: 5 years (Preferred)
• product formulation & Lyophilization: 5 years (Preferred)
• Quality Management System: 5 years (Preferred)

Work Location: One location