REQUIRED COMPETENCIES:

Knowledge, Skills, and Abilities:

• Must have sound knowledge and experience in FDA regulated cGMP Quality Manufacturing operations and processes.
• Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
• Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Must possess an independent mindset.
• Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
• Work is self-directed.
• Confident in making decisions for non-routine issues.
• Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues.
• Develops procedures.
• Proposes solutions for complex issues and works with management to resolve. Follows established procedures and performs work as assigned.
• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
• Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Understands continuous improvement and improves efficiency and productivity within the group or project.
• Builds relationships internally within and with cross functional teams.
• Contributes to goals within the work group.
• Able to recognize conflict and notify management with proposed recommendations for resolution.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Able to effectively multi-task.
• Knowledge of US and global cGMP requirements.
• Excellent verbal and written communication skills.

DUTIES AND RESPONSIBILITIES:

• Build and maintain relationships with Manufacturing Operations, Quality Control, Manufacturing Science & Technology and other departments to effectively accomplish responsibilities make improvements and resolve issues.
• Ensure manufacturing compliance with applicable procedures and batch records.
• Perform real time review of manufacturing batch records.
• Review manufacturing shop floor documentation.
• Issue production batch records and product labels to Operations.
• Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
• Must be skilled in planning and organizing, decision-making, and building relationships.
• Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
• Must be able to work in the cleanroom environment for 6-hour time periods.
• Must be available for weekend and off-shift hours.
• Must be flexible for shift hour changes to support manufacturing.

EDUCATION AND EXPERIENCE:

• Minimum high school diploma required, with equivalent experience. Bachelors degree with 4+ years of relevant work experience preferred
• Aseptic experience preferred, but not required

WORKING CONDITIONS (US Only): Work is performed in a combination of manufacturing cleanroom and office environments, with standard office equipment available and used. Work is generally performed gowned in a cleanroom environment, generally seated but may require standing and walking for up to 50% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.Principle Objective of Position:
The Quality Product Compiance (QPC) Project Coordinator will support the execution of Quality Assurance activities that fall within the Global Quality Key Brands organization. This includes support of marketing and post-marketing changes, global change management implementation planning, as well as supporting other key QPC initiatives and programs. The QPC Project Coordinator will work collaboratively with QPC Management and QPC Project Managers and will also collaborate with the various brand teams and the global Quality organization to reach compliant solutions.

Major Duties and Responsibilities:

• Support the coordination and generation of Annual Product Quality Review (APQRs) Reports
• Work closely with various brand teams and Global Quality organization to communicate specific timelines to team members to ensure on-time deliverables are completed.
• Assist Quality Product Leads (QPLs) with management of Brand strategies to ensure consistency in product release and market supply.
• Support continuous improvement projects to improve Quality Systems and processes, supporting the team with development and utilization of tools for providing standardized work and communications for group initiatives.
• Perform other related duties and assignments, as required.

Education:

• Bachelors degree or equivalent experience
• 3-5 years of experience in a Quality Assurance role within a cGMP biopharmaceutical manufacturing environment.

Experience/Knowledge:

• Working knowledge of quality management systems.
• Excellent technical writing skills with ability to edit materials to ensure accuracy, clarity, and consistency.
• Ability to work collaboratively with cross-functional teams. Experience with working with/or supporting a matrix environment.
• Strong interpersonal, verbal, and written communication.
• Proven track record of successful management of projects and ability to meet critical timelines.

Skills/Competencies: Expertise with MS Office, Word, Excel, Sharepoint, MS Teams,ge Control and document manageme0% Remote (Note: erson MUST be available to report to the BMS Devens, MA Site upon hire. Out of state candidates and/or remote candidates will not be considered for this position

Comments
50% Remote (Note: Person MUST be available to report to the BMS Devens, MA Site upon hire. Out of state candidates and/or remote deviations etc.)

Job Type: Contract

Salary: $25.00 - $30.00 per hour

Schedule:

• 4x12

Experience:

• Quality inspection: 1 year (Preferred)
• CGMP: 1 year (Preferred)

Work Location: One location

Speak with the employer
+91 8474991237

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