Specialist I, QA, Packaging, 3rd shift (BIOPHARMA)

RELOCATION TO BALTIMORE, MD METRO AREA REQUIRED

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

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(BioPharma) Specialist I, QA, Packaging, 3rd shift

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Our team at PharmAllies has teamed up with a mid-sized biopharmaceutical 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
This QA Specialist I role is responsible for assuring the quality of products manufactured, Packaging & Inspection Operations support, CGMP compliance, Quality on the Floor continuous improvement, and client satisfaction.

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

• Perform product and labeling visual over-inspections
• Conduct GMP area in-process audits and walkthroughs
• Complete Quality on the Floor batch record review
• Review and approve GMP records
• Participate in daily tier meetings with site partners
• Partner with Operations to meet schedule requirements and resolve challenges
• Support / assist timely closure of CAPAs, gap analyses, and product complaints
• Maintain company quality and safety standards
• Author and revise standard operating procedures (SOPs)
• Lead Packaging Quality on the Floor improvement initiatives
• Train new Pkg Quality on the Floor personnel on related procedures
• Initiate deviations and assist in area investigations
• Track and trend Pkg QOTF data for monthly metrics reporting
• Train Packaging & Inspection personnel to help resolve issues

This will be a 3rd shift (10:00 pm to 6:30 am) Monday thru Friday position. Overtime and weekend work required, as needed, based on business 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 managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

Bachelor’s degree in relevant field with 5-8 years of GMP experience required; QA/QC role preferred

• Ability to make sound compliance-related decisions with minimal supervision
• Must possess strong attention to detail.
• Ability to navigate computer programs such as Veeva (Document Management System) and SAP (ERP System).
• Proficient knowledge of CGMP.
• Strong communication (written and verbal) and organizational skills.
• Ability to independently manage multiple priorities in a dynamic environment.
• High level of personal/departmental accountability and responsibility.
• Creatively use business concepts and company policies/procedures to solve problems.
• Excellent complex problem-solving and teamwork skills.
• Proficient at resolving issues in creative and innovative ways.
• Exercises good judgment in selecting methods/techniques to achieve positive results.
• Understand and respond appropriately to a diverse population.

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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)?
• Will you be able to commute or relocate to MARYLAND for this job?

Education:

• Bachelor's (Required)

Experience:

• Pharmaceutical: 5 years (Required)
• Biopharmaceutical: 5 years (Preferred)

Work Location: One location