Manpower Engineering
Senior Quality Assurance Inspector
Manpower Engineering, Franklin, New Jersey, us, 07416
Job Title: Senior Quality Assurance Inspector
Location: Onsite in Franklin Township NJ 08873
Pay Rate: $35-$40/hour
Duration: 6 Months contract with high possibility of extension?
Job Summary The Quality Operational Specialist will support manufacturing quality-related activities within a pharmaceutical manufacturing facility. The ideal candidate will have prior GMP inspection and documentation quality review experience, possess strong attention to detail in a fast-paced, multi-task environment, and demonstrate excellent oral and written communication skills while interacting with various levels of management and supporting departments.
Key Responsibilities • ?? ?Conduct audits of the Pharmaceutical Development Manufacturing Facility to ensure compliance with CGMP, DEA, Corporate, and pharmaceutical development SOPs. • ?? ?Perform QA Room Releases, line clearances, equipment releases, and AQL inspections as required. • ?? ?Provide Quality Floor support during batch manufacturing by performing routine quality audits. • ?? ?Support Manufacturing for clinical and commercial batches. • ?? ?Audit executed Batch Records for CGMP compliance and provide responses to customer audits as needed. • ?? ?Audit raw materials, facility logs, and release data. • ?? ?Communicate interdepartmentally to obtain information and facilitate audit corrections. • ?? ?Ensure compliance with Health, Safety, and Environmental responsibilities. • ?? ?Assist with batch investigations as necessary. • ?? ?Be available to work weekends or outside business hours as directed by the department manager. • ?? ?Perform other duties assigned by the manager to support the department and business needs.
Education & Experience Requirements • ?? ?High school diploma or equivalent (GED) with 8+ years of relevant experience in Quality Assurance, Compliance, or Manufacturing within the pharmaceutical industry.
Knowledge & Skills Requirements • ?? ?Strong understanding of compliance regulations and audit techniques. • ?? ?Thorough knowledge of cGMPs and the ability to evaluate facilities, records, processes, procedures, and practices for compliance. • ?? ?Comprehensive understanding of FDA, CGMP, and DEA regulations pertaining to pharmaceutical manufacturing. • ?? ?Good mathematical skills and proficiency in interpreting and adhering to safety procedures. • ?? ?Familiarity with document control, Quality Assurance procedures, and related functions. • ?? ?Ability to manage multiple projects under high pressure while maintaining detail-oriented work. • ?? ?Excellent oral and written communication skills.
Physical Requirements • ?? ?Ability to work, sit, and stand for up to 8 hours a day. • ?? ?Capability to lift 15-30 pounds when necessary. • ?? ?Comfortable performing tasks while wearing Personal Protective Equipment (PPE) such as safety glasses and respirators. ?
If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!
About ManpowerGroup, Parent Company of:
??
Manpower, Experis, Talent Solutions, and Jefferson Wells
ManpowerGroup? (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands -?
Manpower, Experis, Talent Solutions, and Jefferson Wells
?- creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.
Job Summary The Quality Operational Specialist will support manufacturing quality-related activities within a pharmaceutical manufacturing facility. The ideal candidate will have prior GMP inspection and documentation quality review experience, possess strong attention to detail in a fast-paced, multi-task environment, and demonstrate excellent oral and written communication skills while interacting with various levels of management and supporting departments.
Key Responsibilities • ?? ?Conduct audits of the Pharmaceutical Development Manufacturing Facility to ensure compliance with CGMP, DEA, Corporate, and pharmaceutical development SOPs. • ?? ?Perform QA Room Releases, line clearances, equipment releases, and AQL inspections as required. • ?? ?Provide Quality Floor support during batch manufacturing by performing routine quality audits. • ?? ?Support Manufacturing for clinical and commercial batches. • ?? ?Audit executed Batch Records for CGMP compliance and provide responses to customer audits as needed. • ?? ?Audit raw materials, facility logs, and release data. • ?? ?Communicate interdepartmentally to obtain information and facilitate audit corrections. • ?? ?Ensure compliance with Health, Safety, and Environmental responsibilities. • ?? ?Assist with batch investigations as necessary. • ?? ?Be available to work weekends or outside business hours as directed by the department manager. • ?? ?Perform other duties assigned by the manager to support the department and business needs.
Education & Experience Requirements • ?? ?High school diploma or equivalent (GED) with 8+ years of relevant experience in Quality Assurance, Compliance, or Manufacturing within the pharmaceutical industry.
Knowledge & Skills Requirements • ?? ?Strong understanding of compliance regulations and audit techniques. • ?? ?Thorough knowledge of cGMPs and the ability to evaluate facilities, records, processes, procedures, and practices for compliance. • ?? ?Comprehensive understanding of FDA, CGMP, and DEA regulations pertaining to pharmaceutical manufacturing. • ?? ?Good mathematical skills and proficiency in interpreting and adhering to safety procedures. • ?? ?Familiarity with document control, Quality Assurance procedures, and related functions. • ?? ?Ability to manage multiple projects under high pressure while maintaining detail-oriented work. • ?? ?Excellent oral and written communication skills.
Physical Requirements • ?? ?Ability to work, sit, and stand for up to 8 hours a day. • ?? ?Capability to lift 15-30 pounds when necessary. • ?? ?Comfortable performing tasks while wearing Personal Protective Equipment (PPE) such as safety glasses and respirators. ?
If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!
About ManpowerGroup, Parent Company of:
??
Manpower, Experis, Talent Solutions, and Jefferson Wells
ManpowerGroup? (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands -?
Manpower, Experis, Talent Solutions, and Jefferson Wells
?- creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.