Quality Compliance Assessor

COMPLIANCE ASSESSOR

Conshohocken, PA
(Philadelphia area)

Lonza Custom Manufacturing, comprising the business sectors Exclusive Synthesis and Biopharmaceuticals, offers the life science industry world-class services related to research, development and manufacturing of chemicals, intermediates, active pharmaceutical ingredients (API’s) and biotherapeutics from preclinical to commercial quantities. Lonza’s experience and track record in the field of custom manufacturing is unparalleled.

Lonza Custom Manufacturing comprises the two business sectors, Exclusive Synthesis and Biopharmaceuticals. The Lonza Custom Manufacturing organization has nine manufacturing facilities on 3 continents.




ESSENTIAL DUTIES AND RESPONSIBILITIES

- Approves procedures, protocols, validations and qualifications.

- Continuously improves site quality systems and performs trending analysis related to those systems.

- Responsible for general GMP systems audits and reporting and QS/QA system reporting.

- Performs scheduled internal and external audits and inspections.

- Authorizes changes under change control system.

- Represents QA in projects, meetings and reviews.

- Reviews and approves validation documentation, reference procedure and standard operating procedure and computer system validation documentation.

- Evaluates and participates in the issuance, design, development and completion of change notifications for computerized systems necessary to keep them current and up to 21 CFR Part 11 regulatory requirements.

- Compiles and prepares QPR’s, APR’s, and DMF gap analyses.

 

 

ADDITIONAL POSITION REQUIREMENTS

- Investigates non-conformances as they pertain to the manufacturing and testing of pharmaceuticals and medical devices.

- Works with others in a team environment.

- Prepares inspector and audit reports as necessary.

- Successfully completes regulatory and job training requirements.

- Complies with all safety rules, policies and procedures with the intent to maintain a safe working environment. Reports all safety incidents, accidents or injuries to supervisor immediately.

- Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA.  Complies with all company and site policies and procedures.

- Participates in training new personnel.

- Follows all applicable aspects of the site Environmental Management System as it pertains to normal job duties.

- Must be available for overtime work on a scheduled or emergency basis.

- Reviews Standard Operating Procedures.

 

SUPERVISORY RESPONSIBILITIES

Supervises the daily activities of the Laboratory Systems Administrator and QA Coordinator.



** QUALIFICATIONS, EDUCATION and/or EXPERIENCE





 - Bachelor’s degree in chemistry, physics, analytical chemistry or other related pure science.

- 5 or more years experience in the pharmaceutical (or similar) industry  AND

- Minimum 2 years supervisory experience. 

- Thorough understanding of Quality Systems Regulations, cGMP/GLP regulations, Q7a, and FDA requirements for pharmaceuticals.

- Must have knowledge/experience with Equipment Qualification (IQ, OQ, PQ).

- Must have knowledge/experience with Computer Systems Validation (CSV).

- Understanding of statistical analysis such as Six Sigma and trending desired. 

- Experience must include at least 3 years working participation with GMP procedures in the manufacture of bulk pharmaceuticals, food or pharmaceutical products.



 

OTHER SKILLS ABILITIES OR QUALIFICATIONS

- Uses standard computer programs for data entry and calculations and word processing.

- Basic knowledge of SAP in order to run reports to gather data as well as having a knowledge of performing functions such as Batch status, Usage decisions and Posting Stock

- Performs repetitive work with attention to detail while maintaining speed to meet production standards.

- Strong interpersonal skills.

- Organization and ability to manage multiple projects.

- Eye for detail and accuracy.

- Must be available for overtime work as scheduled or on an emergency basis.


SALARY: VERY Competitive

BENEFITS: Excellent Benefits!!

*No Relocation Assistance – Local Candidates Please *



Apply today and send your resume to tina@goldstar-global.com today!