PharmAllies Hiring for QA Specialist – OTF (Biopharma) at Windsor, ON Full Time

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

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

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Biopharma QA Specialist – OTF

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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 Specialist for QA on the Floor is responsible for assuring the Quality of products manufactured at the Company Facility. The QA Specialist I will perform Quality on the Floor functions. Our QA Department provides expertise in problem-solving and process improvements. The QA Specialist will interact with manufacturing personnel and Quality Engineers to provide the guidance necessary to maintain and improve CGMP compliance at the company.

ESSENTIAL FUNCTIONS

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

Essential Duties will include:

• Quality-at-the-source is utilizing on the floor real-time batch record review, disposition, and in-process auditing.
• Performance of walkthroughs of GMP areas to ensure inspection readiness of facility is maintained; includes documentation, follow-up and escalation of observations, and areas of concern.
• Delivers QA oversight of manufacturing processes.
• Provides quality guidance to Manufacturing personnel to manage the resolution of in-process deviations.
• Writes and revises Standard Operating Procedures (SOPs).
• Reviews and approves CGMP documents such as batch records, engineering runs, work orders, logbooks, and reports to ensure compliance with specifications, regulations, and procedures.
• Makes recommendations to QA Management for the release of product based on QA record review and approval.
• Actively involved in daily operations to meet schedules and resolve problems.
• Demonstrate strong organizational skills related to priorities and workload.
• Ability to solve problems independently and within a team environment.
• Train and mentor Production personnel on manufacturing processes to resolve open issues resulting from record reviews, on the floor walkthroughs, and deviation issues.
• Write, review, and assess deviations; perform risk assessments, participate in root cause analysis investigations, and track and follow-up plans.
• Implementation of solutions for identified issues affecting daily manufacturing operations.
• Represents QA to guide the various project and technical meetings, as needed.
• Support and manage existing and/or develop and implement new programs, processes designed to drive continuous improvement.
• Review and approval of Standard Operating Procedures (SOPs) and Master Batch Records (MBRs) on eDocs.
• Review of product master recipes and batch process orders in SAP.
• Supports and assists Quality Systems on timely closure of CAPAs, Gap Analysis and Product Complaints.
• Track and trend metrics for QA on the Floor audits, Logbook audits, and In-Process Audits metrics on a monthly basis for Senior Management.
• Participation in biomedical screening is required.

This will be a 1st shift (6:00 am to 2:30 pm) Monday thru Friday position. Overtime and weekend work are required as needed based on manufacturing needs.The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job, reflecting management’s assignment of essential functions.MINIMUM EDUCATION, EXPERIENCE, SKILLS

BS or BA degree in Science or Engineering with 5-10 years of GMP experience.

• Must have strong attention to detail.
• Ability to manage multiple priorities and tasks in a dynamic environment.
• Excellent written and verbal skills.
• Ability to exercise judgment to determine appropriate corrective actions.
• Ability to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions.
• Ability to use computer programs such as eDocs and SAP.
• Ability to work in a team environment.
• Proficient knowledge of CGMP.
• Coordinate multiple tasks simultaneously.
• Understand and respond to a diverse population.
• Gowning certification required.
• Ability to make sound decisions regarding compliance-related issues with moderate supervision.
• Strong leadership skills; high level of personal/departmental accountability and responsibility.
• Minimum of one year in an FDA-regulated industry.

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Job Type: Full-time

Pay: From $1.00 per year

Additional pay:

• Bonus pay

Benefits:

• Dental care
• Paid time off
• Vision care

Schedule:

• 8 hour shift

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?
• How many years of experience with Master Batch Records (MBRs) on eDocs do you have?

Experience:

• Quality manufacturing processes: 5 years (preferred)
• SAP: 5 years (preferred)