Job description

RELOCATION TO BALTIMORE, MARYLAND METRO AREA REQUIRED! (ASSISTANCE PROVIDED)

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

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QA Manager On-the-Floor (BIO-PHARMA)
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PharmAllies is working alongside a leading innovative pharmaceutical, biopharma, and biotechnology manufacturing company to source talented and experienced professionals whose specialty is within the life science industry. Salaries are very competitive, and the company culture is nurturing, collaborative, and rewarding. Consider joining a company that provides lifesaving medicines to protect and improve lives. Make a difference; apply today!

SUMMARY
The QA Manager On-the-Floor, is responsible for assuring the quality of products manufactured at the Company site facility. This role will supervise the QA On the Floor teams from all shifts and all areas including QA for Production, Packaging and QC. Our QA Department provides expertise in process improvements and problem solving. The QA Manager will interact with teams throughout the organization to provide guidance necessary to improve and maintain CGMP compliance at the company.

RESPONSIBILITIES

• Mentor and develop direct reports to achieve goals based on corporate and site objectives by building team and effectiveness optimizing resources.
• Handling a staff of 6 to 8 individuals who work across multiple shifts.
• Quality at the source utilizing on the floor real time disposition, in process auditing and batch record review.
• Establish strong leadership skills.
• Performance of walkthroughs of GMP areas to ensure inspection readiness of facility is maintained. Includes the documentation, follow up and escalation of observations and areas of concern.
• Cordially involved in daily operations to meet schedules and to resolve problems.
• Write and revise Standard Operating Procedures (SOPs).
• Review and approval of GMP documents such as batch records, logbooks, and reports to ensure compliance with specifications, regulations, and procedures.
• Demonstrate strong organization skills related to priorities and workload. Ability to solve problems independently and within a team environment.
• Instruct and mentor team members on processes to resolve open issues resulting from record reviews, on the floor walk through activities, and deviation issues.
• QA charge of manufacturing processes. Provides quality guidance to manufacturing personnel to manage resolution of in-process deviations.
• Writes, reviews, and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking and follow-up plans.
• Represents Quality Assurance to guide various project and technical meetings, as needed.
• Execution of solutions for identified issues affecting daily manufacturing operations.
• Monitor and trend metrics for QA on the Floor audits, In-Process Audits metrics and Logbook audits monthly for Senior Management.
• Support and guide 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).
• Supports and assists Quality Systems on timely closure of CAPA’s, Gap Analysis and Product Complaints.

EDUCATION, PROFESSIONAL EXPERIENCES AND SKILLS

• BBS or BA degree in Science or Engineering field
• 6-12 years of QA experience with at least 3 years in a GMP environment or FDA regulated industry.
• Minimum of 2-3 years of Supervisor/Manager experience required
• 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 use computer programs such as an electronic Document Management System 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
• Strong leadership skills; high level of personal/departmental accountability and responsibility

E23-00016

Job Type: Full-time

Benefits:

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

Schedule:

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

Experience:

• QA: 7 years (Required)
• Supervisor/Manager: 2 years (Required)
• CGMP: 3 years (Required)

Work Location: In person

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