Address
Form of work Description/Comment: Duration: 12 months
Shift: 11am-8pm
MUST HAVE GMP EXPERIENCE, LOOKING FOR SOMEONE THAT IS VERY ORGANIZED, PREVIOUS EXPERIENCE WITH BATCH RECORDS, DATA ENTRY AND PREVIOUS PHARMA.
IF A CANDIDATE HAS THE DEGREE AND IS A RECENT GRADUATE, MANAGER WILL REVIEW.
The Quality Assurance Department is responsible for providing Leadership and Quality Assurance
Management support within each of the Business Units at Catalent's St. Petersburg site. The
Department has the responsibility for Quality aspects related to Quality Systems, Finished Product
Batch Release, and Change Control. Each Business Unit is comprised of a Quality Assurance
Manager and a Business Unit Manager who liaison in support of designated customers and products.
Review, issuance, and closure of Document Change Requests (DCRs) in accordance with
Catalent's SOPs for all quality documents (i.e. Engineering Drawings, SOPs, Methods, Model
Work Orders, methods, etc.).
Maintenance of the Document Change Request database.
Maintenance of Quality Assurance files for Document Change Requests.
Conducting lifecycle management of quality documents within Documentum.
Authoring and modifying SOPs with input from the change initiators.
Conducting controlled copy printing of master batch records for the production floor.
Issuance of controlled copy reprints for master batch records.
Printing, binding, and distribution of controlled logbooks for all departments..
Conducts off-site storage and retrieval of controlled documents and records in accordance with
proper document retention and Corporate policy.
Assists in the preparation for and facilitation of regulatory and customer audits.
Team
Serves on site project teams. Interfaces with Engineering, Quality Control, Technical Services,
Validation and Manufacturing management in support of providing documentation support for
new product introductions and for changes to existing products.
Ensures that peers and supervisors are informed as to the QA issues that may arise in the
projects that may affect progress
Customer Focus
Support Technical Services/ Engineering/Quality Control/Validation schedules in accordance
with customer and internal project commitments to minimize disruption of the project and
provide documentation in support of business needs.
Interact with counterparts and customer personnel to ensure quality expectations are met
Quality
2
Ensures the adherence to the standards of quality ruled by the current Good Manufacturing
Practices and the Company's Quality Policies.
Participates in the creation and review of current and proposed procedures.
Ensures compliance with cGMPs and departmental procedures.
Proposes and assist in the implementation of quality improvements to Document Control
systems.
Participate in additional quality initiatives as required (e.g. Internal assessments, CEC, etc.)
Education or Equivalent:
Requires a Bachelor's degree in a relevant business discipline or equivalent experience, or
applicable combination. A technical background in chemistry or microbiology is preferred.
Requires a minimum of 3 to 5 years' experience with documentation systems, at least 1-2
years in the pharmaceutical industry. Solid understanding of cGMPs as they apply to
documentation systems.
Knowledge/Skills Requirements: Start Time: 12:00 AM Hours: 8:00am to 5:00pm Location: 101 2725 Scherer Drive North 13-4268760 St. Petersburg FL 33716 United States Education: Additional Job Details: Requires a Bachelor's degree in a relevant business discipline. A technical background in chemistry or microbiology is preferred. Requires a minimum of 3 to 5 years experience with documentation systems, at least 1-2 years in the pharmaceutical industry. Solid understanding of cGMPs as they apply to documentation systems. Direct, hands-on experience with electronic documentation systems; knowledge of Documentum is preferred. Knowledge of LIMS systems, familiarity with bar-coding systems, finished goods label generation, POMS weigh and dispense applications, and JDE is a plus. Proficient technical writing skills are required. Must be well organized, an effective communicator at multiple levels, able to grasp system concepts and communicate their applications. Capable of quickly learning new quality systems and associated software applications for proficient execution of tasks. Must be capable of managing multiple projects with time related constraints in a fast paced contract manufacturing environment. Must possess strong technical writing skills and be able to speak effectively before groups of internal and/or external customers or employee
Shift: 11am-8pm
MUST HAVE GMP EXPERIENCE, LOOKING FOR SOMEONE THAT IS VERY ORGANIZED, PREVIOUS EXPERIENCE WITH BATCH RECORDS, DATA ENTRY AND PREVIOUS PHARMA.
IF A CANDIDATE HAS THE DEGREE AND IS A RECENT GRADUATE, MANAGER WILL REVIEW.
The Quality Assurance Department is responsible for providing Leadership and Quality Assurance
Management support within each of the Business Units at Catalent's St. Petersburg site. The
Department has the responsibility for Quality aspects related to Quality Systems, Finished Product
Batch Release, and Change Control. Each Business Unit is comprised of a Quality Assurance
Manager and a Business Unit Manager who liaison in support of designated customers and products.
Review, issuance, and closure of Document Change Requests (DCRs) in accordance with
Catalent's SOPs for all quality documents (i.e. Engineering Drawings, SOPs, Methods, Model
Work Orders, methods, etc.).
Maintenance of the Document Change Request database.
Maintenance of Quality Assurance files for Document Change Requests.
Conducting lifecycle management of quality documents within Documentum.
Authoring and modifying SOPs with input from the change initiators.
Conducting controlled copy printing of master batch records for the production floor.
Issuance of controlled copy reprints for master batch records.
Printing, binding, and distribution of controlled logbooks for all departments..
Conducts off-site storage and retrieval of controlled documents and records in accordance with
proper document retention and Corporate policy.
Assists in the preparation for and facilitation of regulatory and customer audits.
Team
Serves on site project teams. Interfaces with Engineering, Quality Control, Technical Services,
Validation and Manufacturing management in support of providing documentation support for
new product introductions and for changes to existing products.
Ensures that peers and supervisors are informed as to the QA issues that may arise in the
projects that may affect progress
Customer Focus
Support Technical Services/ Engineering/Quality Control/Validation schedules in accordance
with customer and internal project commitments to minimize disruption of the project and
provide documentation in support of business needs.
Interact with counterparts and customer personnel to ensure quality expectations are met
Quality
2
Ensures the adherence to the standards of quality ruled by the current Good Manufacturing
Practices and the Company's Quality Policies.
Participates in the creation and review of current and proposed procedures.
Ensures compliance with cGMPs and departmental procedures.
Proposes and assist in the implementation of quality improvements to Document Control
systems.
Participate in additional quality initiatives as required (e.g. Internal assessments, CEC, etc.)
Education or Equivalent:
Requires a Bachelor's degree in a relevant business discipline or equivalent experience, or
applicable combination. A technical background in chemistry or microbiology is preferred.
Requires a minimum of 3 to 5 years' experience with documentation systems, at least 1-2
years in the pharmaceutical industry. Solid understanding of cGMPs as they apply to
documentation systems.
Knowledge/Skills Requirements: Start Time: 12:00 AM Hours: 8:00am to 5:00pm Location: 101 2725 Scherer Drive North 13-4268760 St. Petersburg FL 33716 United States Education: Additional Job Details: Requires a Bachelor's degree in a relevant business discipline. A technical background in chemistry or microbiology is preferred. Requires a minimum of 3 to 5 years experience with documentation systems, at least 1-2 years in the pharmaceutical industry. Solid understanding of cGMPs as they apply to documentation systems. Direct, hands-on experience with electronic documentation systems; knowledge of Documentum is preferred. Knowledge of LIMS systems, familiarity with bar-coding systems, finished goods label generation, POMS weigh and dispense applications, and JDE is a plus. Proficient technical writing skills are required. Must be well organized, an effective communicator at multiple levels, able to grasp system concepts and communicate their applications. Capable of quickly learning new quality systems and associated software applications for proficient execution of tasks. Must be capable of managing multiple projects with time related constraints in a fast paced contract manufacturing environment. Must possess strong technical writing skills and be able to speak effectively before groups of internal and/or external customers or employee
