Q & C Analyst Job
Company Name:
J&J Family of Companies
Johnson & Johnson companies are equal opportunity employers.
Q & C Analyst
Description
Johnson & Johnson International is recruiting for a Quality & Compliance (Q&C;) Analyst located in Shepherdsville, KY.
Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life.
The Q&C; Analyst is responsible for the execution of Quality Management Systems and compliance at JOM distribution centers (DC). The Q&C; Analyst serves a single point of contact to the local site quality head on distribution quality related matters and liaises with multiple quality organizations to drive timely resolution of quality related issues. The Q&C; Analyst identifies opportunities to continuously improve quality, cost and time factors, consistent with both Sector and CLS business objectives. Identifies significant business issues, prioritize for action, and lead improvement opportunities and problem solutions. The Q&C; Analyst implements and executes quality assurance programs designed to ensure effective and consistent processes with established standards by performing the following duties:
The Q&C; Analyst is responsible for quality in product receiving process (including receiving inspection) within the DC. Responsible for disposition of damaged packages (incoming) according to predefined agreements with Source, Franchise, and/or Marketing company (co.) Responsible for monitoring of product destruction process. Responsible for quality oversight of quarantine/hold/stop-ship and recall processes within the DC. Responsible for quality oversight of pick/pack/and ship operations, including trending of pick/pack/ and ship errors. Responsible for inventory quality management, including lot reconciliation within the DC. Responsible for ensuring that clinical materials are received and distributed according to agreed upon requirements with clinical organization. Responsible for quality management of patient samples and non-J&J; product maintained within the DC. Responsible for ensuring returned product is dispositioned according to predefined agreements with Source, Franchise, or Marketing co.; responsible for resolving discrepancies in a timely fashion with appropriate partner. Responsible for quality oversight of serialized product processes within the DC.
The Q&C; Analyst is responsible for physical product testing in DC (incoming) (e.g. functional testing, visual inspection & verification). Responsible for physical product testing external (incoming) (e.g. functional testing, visual inspection & verification). Responsible for quality management of repacking, relabeling, over labeling, kitting, and reworking operations conducted within the DC. Responsible for the quality release of product repackaged, relabeled, over labeled, kitted, and reworked within the DC. Responsible for validation/monitoring of cold chain facilities/areas. Responsible for validation of cold chain and controlled ambient pack out & transportation lanes. Responsible for validation of cold chain and controlled ambient pack out & transportation lanes changes. Responsible for quality management of cold chain pack out process. Responsible for validation/monitoring of ambient environment (temperature and humidity as required). Responsible for quality management and oversight of temperature control shipments (outgoing). Responsible for the identification and communication of temperature control excursions occurring within the DC to appropriate partner. Responsible for the quality investigation of temperature control excursions and subsequent remediation activities.
The Q&C; Analyst is responsible for departmental representation for validation of Warehouse Management Systems. Responsible for management of nonconformance and CAPA processes and systems. Responsible for quality records and document management. Responsible for departmental representation for validation, implementation, and changes of calibration/preventive maintenance, CAPA, nonconformance, and document /training management software systems (e.g., DocSpace, ComplianceWire) and document management oversight. Responsible for quality oversight of current standard operating procedures (SOP) and work instructions (WI) in the DC, including SOP/WI development, review and approval. Responsible for departmental representation for change control process. Responsible for departmental representation for training management, including operator certification. Responsible for monitoring of calibration and preventive maintenance systems. Responsible for the capture and processing of DC quality complaints reported to DC (product and service related complaints). Responsible for management of service related complaints, including track and trend. Responsible for internal Quality Agreements between CLS and local operating company / Franchise. Responsible for internal Quality Agreements between CLS Quality and site operations quality.
The Q&C; Analyst is responsible for conducting internal/external quality audits of DCs (schedule, plan, conduct, follow up). Responsible for the management of all Health Authority inspections (e.g. FDA) as well as other logistics and transportation related inspections (e.g., TSA) conducted at all of the DC. Responsible for the execution of DC QSCAN risk evaluation. Responsible for the Quality Management System Review. Responsible for partnering with RTO, ESQI and Enterprise Supplier quality groups in the establishment of Quality Agreements with distribution, logistics, transportation, and material suppliers, as appropriate. Responsible for partnering with RTO, ESQI and Enterprise Supplier quality groups in the qualification of distribution, logistics, transportation, and material suppliers, as appropriate. Responsible for partnering with RTO, ESQI and Enterprise Supplier quality groups in the quality management of distribution, logistics, transportation, and material suppliers, as appropriate. Responsible for ensuring compliance to CFR 210, 211, 820, DEA, TSA and ISO9001 certification requirements, including requirements for obtaining and maintaining certification. Other duties as assigned.
Qualifications
A four 4 year college degree with a minimum of six 6 years pharmaceutical and/or Medical Device (MD) quality assurance, or an equivalent combination of education and experience is required. Distribution experience is preferred. Ability to document work clearly and accurately, and to communicate and present effectively to peers and/or management representatives within a group and/or individual setting is required. Ability to read, write, and understand English, and to perform basic math skills is required. Demonstrated experience in investigative/technical writing in GMP/MD environments is required. Demonstrated proficiency in organizational and project management skills is required. Must be able to work in a team environment and/or independently as the situation requires. Working knowledge of SAP, quality investigation management systems (e.g., EtQ,Trackwise), document management (e.g., DocSpace) / training systems (e.g., ComplianceWire), and warehouse management systems is preferred. Knowledge of and demonstrated skills in sampling methodologies (e.g. ANSI/ASQ standards) is preferred.
This position is located in Shepherdsville, KY and may require occasional travel, up to 10%.
BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies
J2W:LI NA
Primary Location: North America-United States-Kentucky-Shepherdsville
Organization: JOM Pharmaceutical Services, Inc. (6162)
Job Function: Quality Assurance
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
Req ID
Date: Mon, 10 02 2014 00:00:00 GMT
Country: US
State: KY
City: Shepherdsville
Postal Code: 40165
Locale: en_USEstimated Salary: $20 to $28 per hour based on qualifications.
J&J Family of Companies
Johnson & Johnson companies are equal opportunity employers.
Q & C Analyst
Description
Johnson & Johnson International is recruiting for a Quality & Compliance (Q&C;) Analyst located in Shepherdsville, KY.
Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life.
The Q&C; Analyst is responsible for the execution of Quality Management Systems and compliance at JOM distribution centers (DC). The Q&C; Analyst serves a single point of contact to the local site quality head on distribution quality related matters and liaises with multiple quality organizations to drive timely resolution of quality related issues. The Q&C; Analyst identifies opportunities to continuously improve quality, cost and time factors, consistent with both Sector and CLS business objectives. Identifies significant business issues, prioritize for action, and lead improvement opportunities and problem solutions. The Q&C; Analyst implements and executes quality assurance programs designed to ensure effective and consistent processes with established standards by performing the following duties:
The Q&C; Analyst is responsible for quality in product receiving process (including receiving inspection) within the DC. Responsible for disposition of damaged packages (incoming) according to predefined agreements with Source, Franchise, and/or Marketing company (co.) Responsible for monitoring of product destruction process. Responsible for quality oversight of quarantine/hold/stop-ship and recall processes within the DC. Responsible for quality oversight of pick/pack/and ship operations, including trending of pick/pack/ and ship errors. Responsible for inventory quality management, including lot reconciliation within the DC. Responsible for ensuring that clinical materials are received and distributed according to agreed upon requirements with clinical organization. Responsible for quality management of patient samples and non-J&J; product maintained within the DC. Responsible for ensuring returned product is dispositioned according to predefined agreements with Source, Franchise, or Marketing co.; responsible for resolving discrepancies in a timely fashion with appropriate partner. Responsible for quality oversight of serialized product processes within the DC.
The Q&C; Analyst is responsible for physical product testing in DC (incoming) (e.g. functional testing, visual inspection & verification). Responsible for physical product testing external (incoming) (e.g. functional testing, visual inspection & verification). Responsible for quality management of repacking, relabeling, over labeling, kitting, and reworking operations conducted within the DC. Responsible for the quality release of product repackaged, relabeled, over labeled, kitted, and reworked within the DC. Responsible for validation/monitoring of cold chain facilities/areas. Responsible for validation of cold chain and controlled ambient pack out & transportation lanes. Responsible for validation of cold chain and controlled ambient pack out & transportation lanes changes. Responsible for quality management of cold chain pack out process. Responsible for validation/monitoring of ambient environment (temperature and humidity as required). Responsible for quality management and oversight of temperature control shipments (outgoing). Responsible for the identification and communication of temperature control excursions occurring within the DC to appropriate partner. Responsible for the quality investigation of temperature control excursions and subsequent remediation activities.
The Q&C; Analyst is responsible for departmental representation for validation of Warehouse Management Systems. Responsible for management of nonconformance and CAPA processes and systems. Responsible for quality records and document management. Responsible for departmental representation for validation, implementation, and changes of calibration/preventive maintenance, CAPA, nonconformance, and document /training management software systems (e.g., DocSpace, ComplianceWire) and document management oversight. Responsible for quality oversight of current standard operating procedures (SOP) and work instructions (WI) in the DC, including SOP/WI development, review and approval. Responsible for departmental representation for change control process. Responsible for departmental representation for training management, including operator certification. Responsible for monitoring of calibration and preventive maintenance systems. Responsible for the capture and processing of DC quality complaints reported to DC (product and service related complaints). Responsible for management of service related complaints, including track and trend. Responsible for internal Quality Agreements between CLS and local operating company / Franchise. Responsible for internal Quality Agreements between CLS Quality and site operations quality.
The Q&C; Analyst is responsible for conducting internal/external quality audits of DCs (schedule, plan, conduct, follow up). Responsible for the management of all Health Authority inspections (e.g. FDA) as well as other logistics and transportation related inspections (e.g., TSA) conducted at all of the DC. Responsible for the execution of DC QSCAN risk evaluation. Responsible for the Quality Management System Review. Responsible for partnering with RTO, ESQI and Enterprise Supplier quality groups in the establishment of Quality Agreements with distribution, logistics, transportation, and material suppliers, as appropriate. Responsible for partnering with RTO, ESQI and Enterprise Supplier quality groups in the qualification of distribution, logistics, transportation, and material suppliers, as appropriate. Responsible for partnering with RTO, ESQI and Enterprise Supplier quality groups in the quality management of distribution, logistics, transportation, and material suppliers, as appropriate. Responsible for ensuring compliance to CFR 210, 211, 820, DEA, TSA and ISO9001 certification requirements, including requirements for obtaining and maintaining certification. Other duties as assigned.
Qualifications
A four 4 year college degree with a minimum of six 6 years pharmaceutical and/or Medical Device (MD) quality assurance, or an equivalent combination of education and experience is required. Distribution experience is preferred. Ability to document work clearly and accurately, and to communicate and present effectively to peers and/or management representatives within a group and/or individual setting is required. Ability to read, write, and understand English, and to perform basic math skills is required. Demonstrated experience in investigative/technical writing in GMP/MD environments is required. Demonstrated proficiency in organizational and project management skills is required. Must be able to work in a team environment and/or independently as the situation requires. Working knowledge of SAP, quality investigation management systems (e.g., EtQ,Trackwise), document management (e.g., DocSpace) / training systems (e.g., ComplianceWire), and warehouse management systems is preferred. Knowledge of and demonstrated skills in sampling methodologies (e.g. ANSI/ASQ standards) is preferred.
This position is located in Shepherdsville, KY and may require occasional travel, up to 10%.
BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies
J2W:LI NA
Primary Location: North America-United States-Kentucky-Shepherdsville
Organization: JOM Pharmaceutical Services, Inc. (6162)
Job Function: Quality Assurance
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
Req ID
Date: Mon, 10 02 2014 00:00:00 GMT
Country: US
State: KY
City: Shepherdsville
Postal Code: 40165
Locale: en_USEstimated Salary: $20 to $28 per hour based on qualifications.
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