Supervisor, Quality Assurance Operations in Burlington, MA at AMRI

Date Posted: 8/9/2019

Job Snapshot

Job Description

Supervisor, Quality Assurance Operations in Burlington, MA

 

AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

The Supervisor, Quality Assurance Operations will be knowledgeable of industry regulations, industry best practices, and phase appropriate quality systems. This person must be quality focused and understand aseptic processing and the associated quality systems. The Supervisor, Quality Assurance Operations is responsible for oversight of quality operations activities. In this capacity, the incumbent can perform the final disposition of executed batch records, approve quality departures (i.e. unplanned deviations, CAPA's, planned deviations), and approve procedures. Additional responsibilities may include representing Quality Assurance in operations meetings, project meetings, client meetings, and inspections. The Supervisor, Quality Assurance Operations must be highly organized demonstrating excellent communication skills and may organize/delegate workload among Quality Assurance.

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.

Responsibilities

•         Responsible for working cross-functionally with Manufacturing, Process Engineering, Facility, Inspection and Project Management on  Quality Assurance (QA) activities such as the following:

    • Executed/Unexecuted Batch Record Review
    • Executed/Unexecuted Validation/Facility Protocols/Reports
    • Investigation review/writing including Unplanned Deviations, Planned Deviations, Environmental Monitoring Excursions and Equipment Excursions
    • Review of incoming materials/components
    • SOP writing, review and revision
    • Reviewing Change Controls
    • Reviewing Facility Work Orders prior to filing
  • The Supervisor, QA Operations works in coordination with QA Management to ensure client timelines are on schedule and attainable
  • Work in coordination with QA Management to ensure QA staffs are appropriately trained and procedures are being followed
  • Perform QA visual inspection activities associated with clinical and commercial drug product
  • Assist in assuming responsibility for the AMRI compilation of documentation, systems and controls, to ensure inspection-ready quality systems (ISO, FDA, QP, EMEA) for domestic and international inspections and registrations

•         Participate in regulatory and client audits

Responsible for training and mentoring team members

Job Requirements

Requirements

 

•         Bachelor’s degree in life science field; alternate fields of study may be considered in combination with significant Aseptic/Microbiological industry experience

•         5 years of experience of Pharmaceutical/Biotechnology or Medical Device industry experience; Minimum of 5 years of experience in Quality Assurance

•         Excellent written and verbal presentation and communication skills

•         Strong problem solving skills, with the ability to resolve conflict

•         Previously experience in the review of validation (process, IOPQ) protocols and reports preferred

•         Knowledgeable in FDA, cGMPs (21 CFR, 210/211, 820, and 600); ISO 9001 and 13485 a plus

•         Ability to effectively present information to management and/or peers

•         Comfortable working independently in combination with individuals in other departments across the organization

Preferences

•         Former supervisory experience preferred

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds.  Specific vision abilities required by this job include close vision, and ability to adjust focus.

 

Work Environment

While performing the duties of this job, the employee has the potential of being exposed to fumes or airborne particles and toxic or caustic chemicals (wearing proper Personal Protective Equipment will be required in these situations). The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; and may be expected to work with electronic equipment (always being aware of one’s environment and taking proper precautions is required). The noise level in the work environment is usually moderate.

Employee may be responsible for moving and/or generating hazardous waste for treatment, storage and disposal. Affected employee will need to be familiar with the applicable training requirements included in the customized Resources, Conservation and Recovery Act. Employee will understand waste labeling, secondary containment, chemical compatibility, storage time limits, container size and quantity limits, container integrity when waste is left unattended and improper disposal of hazardous materials.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

All interested applicants must apply online. AMRI is an Equal Opportunity Employer, we value diversity and inclusiveness. Minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity are encouraged to apply.
Shift:  Standard 8

Albany Molecular Research, Inc. is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address "jobs@amriglobal.com" to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above-referred email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.

AMRI is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address jobs@amriglobal.com to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above referenced email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.