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Collegeville, PA
United States
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Senior Quality & Compliance Specialist


Under minimal supervision, assists with CBRE and subcontractor/vendor operations and documentation

for compliance with local and global regulatory standards. Must have a good understanding of Quality

Systems and Compliance within a Life Science Environment. Serves as a Quality Assurance (QA)

resource to support documentation and other compliance related activities. Helps to coordinate

implementation of best practices tasks across departments, sites and regions as directed.


Serves as backup for the Compliance Manager or Supervisor as required and provide compliance

guidance and/or assistance to other compliance team members. Support the compliance team in implementation of business requirements around GxP and Non-GxP needs, make decisions when needed and provide guidance. Provide compliance support for issues related to equipment/instruments, processes and systems having significant risk to the Client account. Assist in training sessions to ensure Service Delivery team have an understanding of quality and procedural requirements.

Support the Service Delivery team in delivering the required compliance needs in GxP regulated areas. Coach, mentor, and train Quality Specialists to help build their skills. Represent the compliance function at internal Operational and Client meetings and presentations. Provide quality support including training and system set-up. Promote continuous improvements and share best practices. Report & investigate incidents/deviations and corrective and preventive actions when required.

Quality Arrangements

Provide and maintain the engineering quality standards to ensure that KPI s are met with the aim of

improved performance.

Sign GMP & Non-GMP Documents as delegated by the Line Manager

Ensure continued compliance with company, customer, regulatory and statutory authority requirements.

In conjunction with customer contacts identify areas that require improvement, develop and implement

improvement programs to satisfactory completion.

Assist Compliance Specialist to develop, implement and maintain site audits and performance reviews

when requested to do so.

Identify, develop and implement a maintenance review program so as to focus and improve

maintenance policies and PPM

Actively participate in customer operational and other forums maintaining a high level of company

representation and participation as appropriate.

Provide technical support to the Service Delivery team; maintain the GxP library as a useful source of

technical information.

Assist Line Manager in reviewing staff quality training requirements to ensure that training matrix

identified requirements of the contract are met when requested to do so.

Where appropriate, escalate issues that deviate from the expected and found during maintenance activities on GxP qualified equipment, systems and utilities, which could affect product quality.


Maintain a quality culture between the Company, Client and subcontractors through good communication and documentation.

Operations and Technical Support

Ensuring that quality activities are carried out in compliance with Client quality arrangements and account specific procedures and instructions. Promote improvement in existing work practices through

ownership and commitment from Service Delivery team.

Deviation Investigation

Conduct full RCA related to incidents and deviations, be resourceful in collecting information through systems or colleagues.

Act as a lead investigator in a deviation and work with colleagues to ensure deviations are closed out in a timely manner.

Assist with and review incidence investigation reports and make recommendations to prevent reoccurrences.

Trend deviations and investigate any potential trends or concerns


Provide support for agreeing and closing CAPAs.

Working with CAPA owner to ensure no CAPAs are overdue as per agreed timeline.

Risk Management

Report or escalate potential quality compliance risks to the Line Manager.

Act as point of contact for Client account risks and management of risks in the Risk Management System.

Change Control

Assist with the assessment of change control.

Ensure that changes are controlled, managed and closed out appropriately.

SOP Management

Assist & provide guidance with the preparation and review of Standard Operating Procedures, Instructions, and Work Instructions etc.

Continuous Improvement

Foster and champion compliance initiatives and/or projects.

Audit provide support to Audit team where needed in the following:

Carrying out audits to ensure compliance with Client and Company Quality policies, procedures and


Provide support to Service Delivery team for Level 2, 3 and 4 audits, RCAs, CAPAs as appropriate.

Prepare L1 audit schedule based on risk based approach and trend data.

Ensure L1 schedule is adhered to and executed as per agreed timeline.

Conduct risk-based compliance Level 1 (GxP & Non-GxP), Third Party and other audits on a regular and ad hoc basis.

Control and monitor audit actions to ensure actions are completed as per agreed timeline.

KPIs- provide support to the Analyst where needed in the following:

Collate & trend KPIs / metrics and investigate any potential trends or concerns.

Ensure Compliance KPIs are met as per contract services.

Ensure monthly reports/KPIs commitments are published and submitted to the Line Manager

Bachelor s degree in engineering or applied science. Expertise and practical application with quality systems required. Prior experience in a regulated environment such as the pharmaceutical, medical device or other life science industry preferred. Specialized training or certification in quality assurance audits preferred. Experience with Microsoft Word and Excel. Database and reporting experience preferred. Excellent interpersonal and communication skills to effectively work with management and employees at all levels within an organization, including customers.

Willing to travel to support multi-site operations and audits. Able to work varying shifts, including weekends and holidays as needed. Must have demonstrated experience in a safe, team-based, high-performance, quality-driven environment.

Associated topics: business, company, compliance department, compliance office, corporate, corporate attorney, counsel, courtroom, internal, llp

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