Quality Assurance Manager - On The Floor - Pharmaceuticals

THIS ROLE WILL REQUIRE Maryland RELOCATION

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

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QA Manager - On the Floor

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Our team at PharmAllies has teamed up with a mid-sized biopharma manufacturing firm to supply them with the personnel needed for critical COVID vaccine manufacturing efforts. This company values diversity and growth opportunities for its staff. So, if you want to make a worldwide health impact, take a look at our available positions, and apply today!

Job Description:

The Quality Assurance Manager, On the Floor (OTF) provides quality oversight and management for the site Quality OTF functions to ensure patient safety and compliance with FDA and other applicable health authority requirements. In addition, the QA Manager provides input for continuous improvement and reporting/escalation of quality issues and/or risk mitigation activities. Finally, the QA Manager fosters a culture of quality and compliance through effective leadership and strict adherence to Company core values.

ESSENTIAL FUNCTIONS

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

• Lead the QA OTF team to assure good alignment with client expectations and on-time batch delivery according to plan, including the management of the team to provide 24/7 coverage of manufacturing operations.
• Develop, implement, and optimize quality processes to achieve site objectives. Build and define respective roles and responsibilities within the QA OTF team and execute in a manner to gain efficiencies in support of site operations.
• Must have a strong working knowledge of cGMPs as they relate to Batch Production Record adherence, Good Documentation Practices, and compliant manufacturing of GMP materials. Must also possess the knowledge to support deviation investigation/resolution and generation/implementation of identified CAPAs.
• Strong computer skills and understanding of SAP or similar electronic inventory management system.
• Serve as a member of the site Quality Operations management team. Quality representative to assess real-time potential deviation impact, investigation need and thoroughness of required investigations.
• Maintain the QA OTF program in an inspection ready state by regulatory agencies and clients.
• Lead daily operational initiatives. The successful candidate will have a proven track record of operational execution while retaining high quality of the deliverables.
• Work effectively with various Site functions to align systems across the site.
• Participate in U.S. FDA (CBER) and other regulatory agency inspections to defend quality practices within the Raw Material program.
• Participate in interdepartmental and operational excellence initiatives. Interact with other functional areas to define and execute project requirements and objectives and maintain compliance across the site. Candidate must have track record of working effectively in teams to resolve issues and elevate as appropriate. Ability to prioritize and multitask necessary.

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 Biology, Chemistry, Engineering, or related fields
• A minimum of five (5) years of cGMP Quality experience (QA/QC/Validation)
• A minimum of two (2) years in roles of increasing management or project management responsibility in a biopharmaceutical manufacturing environment
• Strong communication skills: oral/written and listening
• Personal Competencies: Self-awareness, Integrity, Judgment, Vision, and Adaptability
• Interpersonal skills: team building, consensus building, conflict resolution

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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 WISCONSIN for this job?

Education:

• Bachelor's (Required)

Experience:

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

Work Location: One location