Quality & Compliance Specialist - Life Sciences
Job ID
70219
Posted
21-Jun-2022
Service line
GWS Segment
Role type
Full-time
Areas of Interest
Consulting, Data & Analytics
Location(s)
Malvern - Pennsylvania - United States of America, Philadelphia - Pennsylvania - United States of America, Remote - US - Remote - US - United States of America, Spring House - Pennsylvania - United States of America
This is a high-visibility role with strong career advancement potential, serving one of our most prestigious life sciences partnerships.

This position offers remote work opportunities, but requires the ability to report to the Malvern office periodically.

Performance bonus eligible.

RESPONSIBILITIES  


Under moderate supervision, manages the creation, revision, and enforcement of all aspects of the CBRE Quality Management System (QMS), or in situations where CBRE operates within the client's QMS, facilitates the integration and ongoing oversight aspects required by that QMS. This role actively participates with the maintenance of the quality of services (non-regulated) CBRE provides the client. This position interfaces with the client's Quality Assurance team members to support routine quality assurance and quality control operations. This position supports change, event & root cause analysis processes. This role is responsible for creation, revision, and oversight of the training programs, inspection readiness programs, and vendor management programs. This role also participates in CBRE and/or the client's continuous improvement (CI) agenda.


ESSENTIAL DUTIES AND RESPONSIBILITIES  

1.       Conduct Quality Management of:

·       Quality Events including Non-Conformances (NCs) and deviations from procedures.

·       Quality Investigations – Lead Quality Investigations to identify attributing and root causes.

·       CAPA and Correction Record Management and Support with the goal of 100% on time closure.

·       Assist in Preparing the CBRE ELIS Team for on-site inspections/audits and support the Client ELIS Team in responding to on-site inspections/audits.

·       Assist in periodic Services Quality Review (PSQR) – review of all GxP activities done by ELIS team to ensure good documentation practices and Quality Compliance in place.

·       Other actions as needed to support ELIS Team with Quality Compliance issues.

2.       Review ELIS PM and Repair Work Orders (WO s)

·       Ensure completed WO documents meet requirements (example: Good Documentation Practices upheld, verify latest version of procedure was used for execution, etc.).

·       Perform upfront review of qualification status of all instruments/standards used by CBRE and Third Party Vendors during PM, calibration (CAL) or repair of GxP critical assets.

·       Coordinate review needs with local Client Department/Site (example: agree upon next steps in case GxP requirements are not met during PM/CAL/repair)

·       Review the GxP comments in the Client CMMS system (example: Follow up with service lead in case where standard procedure could not be followed)

·       Ensure Good Documentation Practices (correct issues before document close out)

3.       Support Quality Compliance Training Completion

·       Monitor employee training assignments, due dates etc.

·       Coordinate with Client and employees to ensure employees up to date on training

·       Coordinate with Client to ensure employee has the appropriate training matrix

4.       Support ELIS Management Team to achieve Quality Compliance

·       Assist and coordinate with Client and CBRE members of the ELIS Team to ensure overall Team success.

·       Serve as the Single Point of Contact (SPOC) for CBRE ELIS program Quality Compliance at designated client sites.

5.       Support ELIS Vendor Management

·       Ensure new vendors are qualified and meet Client/CBRE quality Compliance requirements.

·       Ensure pre-approved Preventive Maintenance (PM) checklists / protocols from Third Party Vendors are uploaded into the client's Computerized Maintenance Management System (CMMS).

·       Assist with the requalification of vendors as required by Client/CBRE procedures.

6.       Perform GEMBA / Self Inspections

·       Conduct on site self-inspections of the client laboratory areas (may be in conjunction with client).

·       Support the implementation and development of the L1 Self Inspection program.

·       Respond to client led inspections of client laboratory areas.



SUPERVISORY RESPONSIBILITIES  

No formal supervisory responsibilities in this position. Provides informal assistance such as technical guidance, and/or training to coworkers. May coordinate and assign tasks to co-workers within a work unit and/or project.

QUALIFICATIONS  

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

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


EDUCATION and EXPERIENCE  

Bachelor's degree in a related discipline, or equivalent related work experience. 3-5 years related work experience required. Previous experience within a quality organization preferred. Specialized training in quality assurance audits preferred.


CERTIFICATES and/or LICENSES  

FDA, ISO, or similar quality assurance audit related certification preferred. Must have appropriate license and/or certification where required by law.


COMMUNICATION SKILLS  

Ability to comprehend, analyze, and interpret the most complex business documents. Ability to respond effectively to the most sensitive issues. Ability to write reports, manuals, speeches and articles using distinctive style. Ability to make effective and persuasive presentations on complex topics to employees, clients, top management and/or public groups. Ability to motivate and negotiate effectively with key employees, top management, and client groups to take desired action.

Comfortable meeting and engaging with new people.

Warm and engaging demeanor. Ability to assess circumstances, empathize and offer help.


FINANCIAL KNOWLEDGE  

Requires in-depth knowledge of financial terms and principles. Ability to calculate complex figures. Ability to forecast and prepare budgets. Conducts financial/business analysis including the preparation of reports.


REASONING ABILITY  

Ability to solve advanced problems and deal with a variety of options in complex situations. Requires expert level analytical and quantitative skills with proven experience in developing strategic solutions for a growing matrix-based multi-industry sales environment. Draws upon the analysis of others and makes recommendations that have a direct impact on the company.


OTHER SKILLS and ABILITIES  

Experience with Desktop publishing, Microsoft Office Suite and Online Help.

Knowledge of Quality Systems and Compliance within Life Science Environment(s).

Auditing experience in a regulated environment.


SCOPE OF RESPONSIBILITY  

Decisions made with in-depth understanding and interpretation of procedures, company policies and business practices to achieve general results. Responsible for setting department deadlines. Errors in judgment may cause long-term impact to co-workers, supervisor, department and/or line of business.


#INDSJ

CBRE is an equal opportunity/affirmative action employer with a long-standing commitment to providing equal employment opportunity to all qualified applicants regardless of race, color, religion, national origin, sex, sexual orientation, gender identity, pregnancy, age, citizenship, marital status, disability, veteran status, political belief, or any other basis protected by applicable law.

NOTE: An additional requirement for this role is the ability to comply with COVID-19 health and safety protocols, including COVID-19 vaccination proof and/or rigorous testing.