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Form of work Position Details:
Our client, a world-leading Pharmaceutical Company in Fort Washington, PA is currently looking for an Manufacturing Quality Associate I / Third Shift to join their expanding team.
Job Title: Manufacturing Quality Associate I / Pharma Industry / Third Shift
Duration: 17 months contract, extendable up to 24 months
Location: Fort Washington, PA
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Position Title: Quality Assurance Associate I
Department Name: Quality - Quality Assurance Reports to (title): Quality Assurance Operations Supervisor
Position Summary:
The position is responsible for providing daily Quality Assurance support to the manufacturing site to ensure internal and regulatory cGMP and CFR requirements are met.
Quality Assurance support areas include but are not limited to Batch Record Review, Product Release, Standard Operating Procedures, Investigations, CAPA, Change Control, Shop Floor Audits.
The position will interact with other departments including Manufacturing, Packaging, Quality Laboratories, Quality Systems, Validation, Engineering, Maintenance and other departments as it relates to site Quality Assurance responsibilities.
The Company's management reserves the right to add, delete or otherwise alter assigned duties at any time.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
The requirements listed 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. III.
Responsibilities:
(Define key accountabilities and/or activities.) Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies' policies, procedures and guidelines, this position:
Ensure quality and compliance in all my actions by: All employees
Attend GMP training on the schedule designated for my role and as appropriate for my role.
Adhere to strict compliance with procedures applicable to my role.
Exercise the highest level of integrity in the tasks that I perform.
In a timely and prompt manner, identify, report and seek correction for deviations noted in my workplace.
Embrace a behavior of employee involvement and commitment to doing the job right the first time.
1. Quality Assurance and Compliance Focus
Provides daily 'Shop Floor" QA support to warehouse, bulk manufacturing and packaging lines.
Provides leadership support to QA Shop Floor activities including communication of quality events to management.
Performs or supports activities related to Batch Record Review, Raw Material, Bulk, and Finished Product Releases.
Provides support to Investigations and/or Investigation Protocols..
Performs or supports activities related Line Audits, Line or Area Cleaning Verifications
Participates in design of quality processes and creation/modification/approval of Standard Operating Procedures (SOP's).
Provides support to Consumer Complaint investigations.
Provide QA support to various project teams, as needed.
Actively supports Site metrics, compliance improvement and training initiatives.
2. Customer and Performance Improvement Focus
Provide support to capturing of site metrics and promote improvement opportunities.
Facilitate resolution of issues to improve site metrics.
3. People & Organization Focus
Provides training and direction as needed to new employees
Teams with Department members for process feedback and continuous improvement opportunities
Represents Quality Assurance in positive manner
4. Performs other related duties as required.
Requirements:
(List types of requirements and typical years required)
Education:
BS /BA College Degree (Science or Technical Degree preferred) or Equivalent
Experience:
BS/BA College Degree with 2 years of related Industry Experience, with proven success in cGMP/compliance environment
Active cGMP Interpretation and Application Experience
Demonstrated leadership- possesses the ability to lead a team
Strong Organizational Skills
Strong Communication/Interpersonal and Facilitation Skills (verbal, written and presentation)
Problem Solving/Investigation Experience preferred
Expertise in Handling Multiple Priorities Physical Demands: N/A
Knowledge, Skills and Abilities:
Minimum Bachelor College Degree preferably in a Science
2 + years professional experience in a regulated industry
Process and Systems Experience, especially with SOPs, MBRs, Change Controls, Non-Conformance Investigation Documentation
Experience with Liquid Dose processing and packaging technology preferred.
Validation Experience preferred
Certifications/Licenses: N/A
Global Leadership Profile Requirements: N/A
Other Requirements: N/A
Position Dimensions:
Employees Supervised: Direct Indirect Exempt: Non-Exempt: Personal Contacts: Internal: External: Average With all departments and at all company levels. With other Company management, local, state and federal regulatory agencies, industrial community management, contractors and service providers.
Responsibilities:
Yes No Budget: N/A Other Dimensions: Work Environment and Conditions: Tools, Equipment, Machines, Materials: Environment Health & Safety: Comply with the requirements established in the Environmental Health and Safety (EHS) Program VI. Approvals: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all the responsibilities, duties & skills required of personnel so classified.
Third Shift role - Sun night through Fri morning (10:00 pm - 6:30 am)
Will train on First Shift - Mon through Fri 8:00 am - 5:00 pm
Our client, a world-leading Pharmaceutical Company in Fort Washington, PA is currently looking for an Manufacturing Quality Associate I / Third Shift to join their expanding team.
Job Title: Manufacturing Quality Associate I / Pharma Industry / Third Shift
Duration: 17 months contract, extendable up to 24 months
Location: Fort Washington, PA
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Position Title: Quality Assurance Associate I
Department Name: Quality - Quality Assurance Reports to (title): Quality Assurance Operations Supervisor
Position Summary:
The position is responsible for providing daily Quality Assurance support to the manufacturing site to ensure internal and regulatory cGMP and CFR requirements are met.
Quality Assurance support areas include but are not limited to Batch Record Review, Product Release, Standard Operating Procedures, Investigations, CAPA, Change Control, Shop Floor Audits.
The position will interact with other departments including Manufacturing, Packaging, Quality Laboratories, Quality Systems, Validation, Engineering, Maintenance and other departments as it relates to site Quality Assurance responsibilities.
The Company's management reserves the right to add, delete or otherwise alter assigned duties at any time.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
The requirements listed 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. III.
Responsibilities:
(Define key accountabilities and/or activities.) Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies' policies, procedures and guidelines, this position:
Ensure quality and compliance in all my actions by: All employees
Attend GMP training on the schedule designated for my role and as appropriate for my role.
Adhere to strict compliance with procedures applicable to my role.
Exercise the highest level of integrity in the tasks that I perform.
In a timely and prompt manner, identify, report and seek correction for deviations noted in my workplace.
Embrace a behavior of employee involvement and commitment to doing the job right the first time.
1. Quality Assurance and Compliance Focus
Provides daily 'Shop Floor" QA support to warehouse, bulk manufacturing and packaging lines.
Provides leadership support to QA Shop Floor activities including communication of quality events to management.
Performs or supports activities related to Batch Record Review, Raw Material, Bulk, and Finished Product Releases.
Provides support to Investigations and/or Investigation Protocols..
Performs or supports activities related Line Audits, Line or Area Cleaning Verifications
Participates in design of quality processes and creation/modification/approval of Standard Operating Procedures (SOP's).
Provides support to Consumer Complaint investigations.
Provide QA support to various project teams, as needed.
Actively supports Site metrics, compliance improvement and training initiatives.
2. Customer and Performance Improvement Focus
Provide support to capturing of site metrics and promote improvement opportunities.
Facilitate resolution of issues to improve site metrics.
3. People & Organization Focus
Provides training and direction as needed to new employees
Teams with Department members for process feedback and continuous improvement opportunities
Represents Quality Assurance in positive manner
4. Performs other related duties as required.
Requirements:
(List types of requirements and typical years required)
Education:
BS /BA College Degree (Science or Technical Degree preferred) or Equivalent
Experience:
BS/BA College Degree with 2 years of related Industry Experience, with proven success in cGMP/compliance environment
Active cGMP Interpretation and Application Experience
Demonstrated leadership- possesses the ability to lead a team
Strong Organizational Skills
Strong Communication/Interpersonal and Facilitation Skills (verbal, written and presentation)
Problem Solving/Investigation Experience preferred
Expertise in Handling Multiple Priorities Physical Demands: N/A
Knowledge, Skills and Abilities:
Minimum Bachelor College Degree preferably in a Science
2 + years professional experience in a regulated industry
Process and Systems Experience, especially with SOPs, MBRs, Change Controls, Non-Conformance Investigation Documentation
Experience with Liquid Dose processing and packaging technology preferred.
Validation Experience preferred
Certifications/Licenses: N/A
Global Leadership Profile Requirements: N/A
Other Requirements: N/A
Position Dimensions:
Employees Supervised: Direct Indirect Exempt: Non-Exempt: Personal Contacts: Internal: External: Average With all departments and at all company levels. With other Company management, local, state and federal regulatory agencies, industrial community management, contractors and service providers.
Responsibilities:
Yes No Budget: N/A Other Dimensions: Work Environment and Conditions: Tools, Equipment, Machines, Materials: Environment Health & Safety: Comply with the requirements established in the Environmental Health and Safety (EHS) Program VI. Approvals: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all the responsibilities, duties & skills required of personnel so classified.
Third Shift role - Sun night through Fri morning (10:00 pm - 6:30 am)
Will train on First Shift - Mon through Fri 8:00 am - 5:00 pm
