What are the responsibilities and job description for the QC Supervisor position at Aurobindo Pharma USA, Inc.?
Division Overview:
Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical prouct development and manufacturing. Aurolife has a 10 year history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has given Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.
Job Overview:
JOB SUMMARY
This key supervisory position in Quality Control Laboratory providing project/ task management and technical leadership. Supervisor is responsible for conducting stability testing program as per ICH guidelines/ in-house SOP’s. Supervisor is responsible for the training, development, necessary resources, information & guidance are provided, and management of team members. The incumbent will also utilize his or her technical expertise, knowledge of pharmaceutical testing (e.g critical issues involved in test methods, laboratory instrumentation & basic principle (s) of operation, etc), current regulatory guidelines, organizational and communication skills to ensure safe, efficient and effective laboratory operations. This is a critical role within the QC department that oversees the activities performed in the team are as per applicable rules and regulations (e.g current USP-NF, cGMP, cGLP, Safety, DEA, in-house SOP’s and testing procedures).
Accountable for ensuring that the analytical measurements are accurate and that methods are in compliance with USFDA, and /or other applicable regulatory guidelines, cGMP and corporate requirements. Expected to plan, organize and schedule the activities based on the situation.
Perform troubleshooting and investigations. Demonstrates critical thinking skills and creativity when solving problems.
Planning and procure all laboratory chemicals and consumables as per requirement on time.
Planning/assigning calibration activities of Laboratory instruments/equipments.
Prepare and/or Review Test Procedures, SOPs, and Protocols.
Review of day-to-day analytical data generated in the Laboratory. Maintains and updates essential Laboratory documents as per current regulatory guidelines.
Review and compilation of Analytical data required for filings and provide the support to address for any agency queries.
Take a lead to work on special tasks as assigned by management.
Responsible for internal audits and external audits such as preapproval, cGMP and post approval inspections by USFDA.
Thoroughly perform/ write the investigations related to Labevent, OOS, OOT, Deviations and on-time closing.
Participate in Change control process and complete the impact assessment, as an SME need to verify the proposed changes and impact assessment.
Responsible for maintaining the lab in clean condition.
Complete the Method Transfer activities on-time by coordinating with the Originating Laboratories.
Perform internal audits of the Laboratory, including both technical and quality systems audits.
Perform and document corrective action, including followup monitoring to gauge the effectiveness of the corrective action.
Maintain training records for all laboratory staff, including Demonstrations of Capability.
REPORTING RELATIONSHIPS
None
DUTIES & ESSENTIAL JOB FUNCTIONS
DUTIES & ESSENTIAL JOB FUNCTINS
PERCENT OF TIME
(Time of all duties must add up to 100%)
FREQUENCY
(daily, weekly, monthly, quarterly, yearly)
ESSENTIAL DUTIES (List in order of importance – most significant first)
60%
Daily
Assigning tasks, support team members and other departments, providing necessary resources, information and guidance.
15%
Daily
Handling Lab Incidents/Deviations/OOS/OOT/Change controls and Review of QC Reports/Documents/Day-to-Day Laboratory data
15%
Daily
Testing of samples assigned and reporting the results generated from testing activity
10%
Daily
Prepare/Review/Compilation of QC related documents for Regulatory submissions
OTHER FUNCTIONS AND RESPONSIBILITIES
Perform other related duties as required and / or assigned
QUALIFICATIONS
Minimum BS with Scientific field
BS with Chemistry is one of the subjects would be preferable
Minimum 5-8 years experience in pharmaceuticals. Should have at least 3-5 experience with generic pharmaceuticals. More QC experience in generic pharmaceuticals industries would be an added advantage
Knowledge in Method Development & Method Validation would be preferable and previous supervisory experience would be added advantage
Up-to-date knowledge in USP/ICH/FDA /cGLP/cGMP/Safety regulations would be added advantage
Experience handling and testing Control Substances would be preferable
Ability to learn quickly & Train team members
Technical, Administrative, Decision making, Communication skills and Ability to work under pressure
Knowledge in operating the LIMS would be preferable
.
ANY REQUIRED LICENSES/CERTIFICATIONS
None
PHYSICAL REQUIREMENTS/WORK ENVIRONMENT
PHYSICAL REQUIREMENTS AND WORK ENVIRONMENT
1. Check the frequency and number of hours a day the worker is required to do the following specific types of activities:
ACTIVITY
FREQUENCY
# OF HOURS A DAY
CONTINUOUS
INTERMITTENT
1
2
3
4
5
6
7
8
8
a. Sitting
Up to 8 Hours/day
b. Walking
Up to 8 Hours/day
c. Standing
Up to 8 Hours/day
d. Bending
´
e. Squatting
f. Climbing
g. Kneeling
h. Twisting
i. Lifting
´
LIFTING ð ð R ð
0-10 kgs. 10-15 kgs. 15-30 kgs. Over 30 kgs.
2a. HAND MANIPULATION REQUIRED? ___´__Yes (If yes, complete a,b,c,d,e) _____No
2b. Repetitive hand movements? __´__Yes _____No
2c. Simple Grasping?
Right Hand_____
Yes__´___ No_____
Left Hand_____
Yes__´____ No_____
2d. Power Grasping?
Right Hand_____
Yes_____ No__´___
Left Hand_____
Yes_____ No__´___
2e. Pushing Pulling?
Right Hand_____
Yes__´___ No_____
Left Hand_____
Yes___´___ No_____
2f. Fine manipulation:
Right Hand_____
Yes__´___ No_____
Left Hand_____
Yes__´___ No_____
3. (a) Does the job require worker to reach or work above the shoulder? ___´__Yes ____No _____Frequency
(b) Reaching at or below shoulder level? ___´__Yes _____No _____Frequency (ONCE IN A WHILE)
4. Does the job require use of his/her feet to operate foot controls or _____Yes __´__No
for repetitive movement?
5. Are there special visual or auditory requirements? _____Yes __´__No
Describe: Working with computer terminal
Need to work with computer terminal while reviewing the data and documents
WORK ENVIRONMENT:
a. Does the employee work near moving mechanical parts; in high, precarious places; and in outside weather conditions? ___´__Yes _____No
b. Is the employee exposed to fumes or airborne particles? ___´___Yes ______No
BLOOD/FLUID EXPOSURE RISK: (check the right category) N/A
_______Category I: Tasks involve exposure to blood, fluids or tissue
_______Category II: Usual tasks do not involve exposure to blood, body fluid, or tissues but job may require performing unplanned Category I tasks.
___´__Category III: Tasks involve no exposure to blood, body fluids, or tissues. Category I tasks are not a condition of employment.
Responsibilities:
1. Accountable for ensuring that the analytical measurements are accurate and that methods are in compliance with USFDA, and /or other applicable regulatory guidelines, cGMP and corporate requirements. Expected to plan, organize and schedule the activities based on the situation. 2. Perform troubleshooting and investigations. Demonstrates critical thinking skills and creativity when solving problems. 3. Planning and procure all laboratory chemicals and consumables as per requirement on time. 4. Planning/assigning calibration activities of Laboratory instruments/equipments. 5. Prepare and/or Review Test Procedures, SOPs, and Protocols. 6. Review of day-to-day analytical data generated in the Laboratory. Maintains and up dates essential Laboratory documents as per current regulatory guidelines. 7. Review and compilation of Analytical data required for filings. 8. Take a lead to work on special tasks as assigned by management. 9. Responsible for internal audits and external audits such as pre approval, cGMP and post approval inspections by USFDA.
Qualifications - Skills & Requirements:
Lifting 8 Hours - 0-10 Pounds
Sitting 1-4 Hours
Bending 1-4 Hours
Standing 4-8 Hours
Walking 1-4 Hours
Blood/Fluid Exposure Risk: Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment. We Are An Equal Opportunity Employer: Aurobindo Pharma USA, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical prouct development and manufacturing. Aurolife has a 10 year history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has given Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.
Job Overview:
JOB SUMMARY
This key supervisory position in Quality Control Laboratory providing project/ task management and technical leadership. Supervisor is responsible for conducting stability testing program as per ICH guidelines/ in-house SOP’s. Supervisor is responsible for the training, development, necessary resources, information & guidance are provided, and management of team members. The incumbent will also utilize his or her technical expertise, knowledge of pharmaceutical testing (e.g critical issues involved in test methods, laboratory instrumentation & basic principle (s) of operation, etc), current regulatory guidelines, organizational and communication skills to ensure safe, efficient and effective laboratory operations. This is a critical role within the QC department that oversees the activities performed in the team are as per applicable rules and regulations (e.g current USP-NF, cGMP, cGLP, Safety, DEA, in-house SOP’s and testing procedures).
Accountable for ensuring that the analytical measurements are accurate and that methods are in compliance with USFDA, and /or other applicable regulatory guidelines, cGMP and corporate requirements. Expected to plan, organize and schedule the activities based on the situation.
Perform troubleshooting and investigations. Demonstrates critical thinking skills and creativity when solving problems.
Planning and procure all laboratory chemicals and consumables as per requirement on time.
Planning/assigning calibration activities of Laboratory instruments/equipments.
Prepare and/or Review Test Procedures, SOPs, and Protocols.
Review of day-to-day analytical data generated in the Laboratory. Maintains and updates essential Laboratory documents as per current regulatory guidelines.
Review and compilation of Analytical data required for filings and provide the support to address for any agency queries.
Take a lead to work on special tasks as assigned by management.
Responsible for internal audits and external audits such as preapproval, cGMP and post approval inspections by USFDA.
Thoroughly perform/ write the investigations related to Labevent, OOS, OOT, Deviations and on-time closing.
Participate in Change control process and complete the impact assessment, as an SME need to verify the proposed changes and impact assessment.
Responsible for maintaining the lab in clean condition.
Complete the Method Transfer activities on-time by coordinating with the Originating Laboratories.
Perform internal audits of the Laboratory, including both technical and quality systems audits.
Perform and document corrective action, including followup monitoring to gauge the effectiveness of the corrective action.
Maintain training records for all laboratory staff, including Demonstrations of Capability.
REPORTING RELATIONSHIPS
None
DUTIES & ESSENTIAL JOB FUNCTIONS
DUTIES & ESSENTIAL JOB FUNCTINS
PERCENT OF TIME
(Time of all duties must add up to 100%)
FREQUENCY
(daily, weekly, monthly, quarterly, yearly)
ESSENTIAL DUTIES (List in order of importance – most significant first)
60%
Daily
Assigning tasks, support team members and other departments, providing necessary resources, information and guidance.
15%
Daily
Handling Lab Incidents/Deviations/OOS/OOT/Change controls and Review of QC Reports/Documents/Day-to-Day Laboratory data
15%
Daily
Testing of samples assigned and reporting the results generated from testing activity
10%
Daily
Prepare/Review/Compilation of QC related documents for Regulatory submissions
OTHER FUNCTIONS AND RESPONSIBILITIES
Perform other related duties as required and / or assigned
QUALIFICATIONS
Minimum BS with Scientific field
BS with Chemistry is one of the subjects would be preferable
Minimum 5-8 years experience in pharmaceuticals. Should have at least 3-5 experience with generic pharmaceuticals. More QC experience in generic pharmaceuticals industries would be an added advantage
Knowledge in Method Development & Method Validation would be preferable and previous supervisory experience would be added advantage
Up-to-date knowledge in USP/ICH/FDA /cGLP/cGMP/Safety regulations would be added advantage
Experience handling and testing Control Substances would be preferable
Ability to learn quickly & Train team members
Technical, Administrative, Decision making, Communication skills and Ability to work under pressure
Knowledge in operating the LIMS would be preferable
.
ANY REQUIRED LICENSES/CERTIFICATIONS
None
PHYSICAL REQUIREMENTS/WORK ENVIRONMENT
PHYSICAL REQUIREMENTS AND WORK ENVIRONMENT
1. Check the frequency and number of hours a day the worker is required to do the following specific types of activities:
ACTIVITY
FREQUENCY
# OF HOURS A DAY
CONTINUOUS
INTERMITTENT
1
2
3
4
5
6
7
8
8
a. Sitting
Up to 8 Hours/day
b. Walking
Up to 8 Hours/day
c. Standing
Up to 8 Hours/day
d. Bending
´
e. Squatting
f. Climbing
g. Kneeling
h. Twisting
i. Lifting
´
LIFTING ð ð R ð
0-10 kgs. 10-15 kgs. 15-30 kgs. Over 30 kgs.
2a. HAND MANIPULATION REQUIRED? ___´__Yes (If yes, complete a,b,c,d,e) _____No
2b. Repetitive hand movements? __´__Yes _____No
2c. Simple Grasping?
Right Hand_____
Yes__´___ No_____
Left Hand_____
Yes__´____ No_____
2d. Power Grasping?
Right Hand_____
Yes_____ No__´___
Left Hand_____
Yes_____ No__´___
2e. Pushing Pulling?
Right Hand_____
Yes__´___ No_____
Left Hand_____
Yes___´___ No_____
2f. Fine manipulation:
Right Hand_____
Yes__´___ No_____
Left Hand_____
Yes__´___ No_____
3. (a) Does the job require worker to reach or work above the shoulder? ___´__Yes ____No _____Frequency
(b) Reaching at or below shoulder level? ___´__Yes _____No _____Frequency (ONCE IN A WHILE)
4. Does the job require use of his/her feet to operate foot controls or _____Yes __´__No
for repetitive movement?
5. Are there special visual or auditory requirements? _____Yes __´__No
Describe: Working with computer terminal
Need to work with computer terminal while reviewing the data and documents
WORK ENVIRONMENT:
a. Does the employee work near moving mechanical parts; in high, precarious places; and in outside weather conditions? ___´__Yes _____No
b. Is the employee exposed to fumes or airborne particles? ___´___Yes ______No
BLOOD/FLUID EXPOSURE RISK: (check the right category) N/A
_______Category I: Tasks involve exposure to blood, fluids or tissue
_______Category II: Usual tasks do not involve exposure to blood, body fluid, or tissues but job may require performing unplanned Category I tasks.
___´__Category III: Tasks involve no exposure to blood, body fluids, or tissues. Category I tasks are not a condition of employment.
Responsibilities:
1. Accountable for ensuring that the analytical measurements are accurate and that methods are in compliance with USFDA, and /or other applicable regulatory guidelines, cGMP and corporate requirements. Expected to plan, organize and schedule the activities based on the situation. 2. Perform troubleshooting and investigations. Demonstrates critical thinking skills and creativity when solving problems. 3. Planning and procure all laboratory chemicals and consumables as per requirement on time. 4. Planning/assigning calibration activities of Laboratory instruments/equipments. 5. Prepare and/or Review Test Procedures, SOPs, and Protocols. 6. Review of day-to-day analytical data generated in the Laboratory. Maintains and up dates essential Laboratory documents as per current regulatory guidelines. 7. Review and compilation of Analytical data required for filings. 8. Take a lead to work on special tasks as assigned by management. 9. Responsible for internal audits and external audits such as pre approval, cGMP and post approval inspections by USFDA.
Qualifications - Skills & Requirements:
- Minimum BS with Scientific field • BS with Chemistry is one of the subjects would be preferable • Minimum 5-8 years experience in pharmaceuticals. Should have at least 3-5 experience with generic pharmaceuticals. More QC experience in generic pharmaceuticals industries would be an added advantage • Knowledge in Method Development & Method Validation would be preferable and previous supervisory experience would be added advantage • Up-to-date knowledge in USP/ICH/FDA /cGLP/cGMP/Safety regulations would be added advantage • Experience handling and testing Control Substances would be preferable • Ability to learn quickly & Train team members • Technical, Administrative, Decision making, Communication skills and Ability to work under pressure • Knowledge in operating the LIMS would be preferable
- Minimum BS with Scientific field • BS with Chemistry is one of the subjects would be preferable • Minimum 5-8 years experience in pharmaceuticals. Should have at least 3-5 experience with generic pharmaceuticals. More QC experience in generic pharmaceuticals industries would be an added advantage • Knowledge in Method Development & Method Validation would be preferable and previous supervisory experience would be added advantage • Up-to-date knowledge in USP/ICH/FDA /cGLP/cGMP/Safety regulations would be added advantage • Experience handling and testing Control Substances would be preferable • Ability to learn quickly & Train team members • Technical, Administrative, Decision making, Communication skills and Ability to work under pressure • Knowledge in operating the LIMS would be preferable
Lifting 8 Hours - 0-10 Pounds
Sitting 1-4 Hours
Bending 1-4 Hours
Standing 4-8 Hours
Walking 1-4 Hours
Blood/Fluid Exposure Risk: Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment. We Are An Equal Opportunity Employer: Aurobindo Pharma USA, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
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