Quality Specialist Visa Sponsorship Jobs in Pennsylvania
Pennsylvania's quality specialist roles span pharmaceutical manufacturing in the Philadelphia suburbs, medical device production around Pittsburgh, and food processing operations statewide. Major employers including Merck, Johnson & Johnson, and Siemens have sponsored international workers for quality roles. Cities like Philadelphia, Pittsburgh, and Allentown concentrate the most active hiring.
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Get Access To All JobsSUMMARY
The Quality Compliance & Systems Specialist is an essential part of the Quality Assurance team and will be responsible for ensuring that the site Quality Systems (CAPA, Non-Conformance, Trending, Change Management, Complaints) are being followed and are up to current industry standards. In addition, the Quality Systems Specialist II is expected to author Annual Product Reviews as well as ensure execution of policies and practices for compliance with DEA Controlled Substance regulations, requirements, and expectations.
Responsibilities
- Ensures Quality Systems (CAPA, Non-Conformance, Trending, Data Integrity, Customer Complaints, Change Control, etc.) compliance and drives improvements.
- Provide guidance and ensure corrective and preventive actions are adequately and timely implemented and monitor their closure and effectiveness.
- Utilize EDMS/EQMS for processing complaints, reviewing and revising documents, managing training configurations and user groups.
- Create Annual Product Reviews for management decision making.
- Investigate Customer Complaints through follow-up and resolution.
- Interact with Customer’s Quality associates to fulfill client needs.
- Participate in Customer/Regulatory audits.
- Audits quality systems and manufacturing practices and ensures that products are produced to specification and that all documentation requirements are consistently adhered to meet safety, quality, and regulatory requirements.
- Proactive in continuous improvement of quality systems and procedures including writing and revising SOPs.
- Conducts investigations to determine root cause and recommends and implements corrective, preventative actions.
- Collaborate with all departments within the company as required.
- Ensure facility adherence to cGMP’s and SOP’s.
- Understands DEA regulations and updates policies, procedures, and practices for compliance with applicable rules and regulations.
- Assists with DEA compliance training.
- Monitor the use of DEA 222 order forms for compliance with DEA requirements.
- Review cGMP documentation related to controlled substances.
- Assist with inventory accountability and reconciliation for controlled substances.
- Coordination of controlled drugs destructions in accordance with DEA regulations.
- Maintain the confidentiality of pertinent information.
- Trend, prepare and present quality metrics to senior management.
- Other duties as assigned.
REQUIRED SKILLS AND QUALIFICATIONS
- Bachelor’s degree; 5+ years of dynamic Quality Assurance or Quality Control experience in the life sciences industry.
- Advanced knowledge GMP requirements.
- Understanding of Quality Systems pertaining to a bulk pharmaceutical, solid oral dosage manufacturing and packaging environment is preferred.
- Operational knowledge of European GMPs preferred.
- Must possess knowledge of DEA regulations and industry guidances, policies, and procedures pertaining to the DEA Controlled Substance.
- Excellent document quality.
- Ability to analyze and synthesize.
- Excellent interpersonal written and oral communication skills.
- Ability to coordinate, contribute to, and work within a cross-functional team.
SUMMARY
The Quality Compliance & Systems Specialist is an essential part of the Quality Assurance team and will be responsible for ensuring that the site Quality Systems (CAPA, Non-Conformance, Trending, Change Management, Complaints) are being followed and are up to current industry standards. In addition, the Quality Systems Specialist II is expected to author Annual Product Reviews as well as ensure execution of policies and practices for compliance with DEA Controlled Substance regulations, requirements, and expectations.
Responsibilities
- Ensures Quality Systems (CAPA, Non-Conformance, Trending, Data Integrity, Customer Complaints, Change Control, etc.) compliance and drives improvements.
- Provide guidance and ensure corrective and preventive actions are adequately and timely implemented and monitor their closure and effectiveness.
- Utilize EDMS/EQMS for processing complaints, reviewing and revising documents, managing training configurations and user groups.
- Create Annual Product Reviews for management decision making.
- Investigate Customer Complaints through follow-up and resolution.
- Interact with Customer’s Quality associates to fulfill client needs.
- Participate in Customer/Regulatory audits.
- Audits quality systems and manufacturing practices and ensures that products are produced to specification and that all documentation requirements are consistently adhered to meet safety, quality, and regulatory requirements.
- Proactive in continuous improvement of quality systems and procedures including writing and revising SOPs.
- Conducts investigations to determine root cause and recommends and implements corrective, preventative actions.
- Collaborate with all departments within the company as required.
- Ensure facility adherence to cGMP’s and SOP’s.
- Understands DEA regulations and updates policies, procedures, and practices for compliance with applicable rules and regulations.
- Assists with DEA compliance training.
- Monitor the use of DEA 222 order forms for compliance with DEA requirements.
- Review cGMP documentation related to controlled substances.
- Assist with inventory accountability and reconciliation for controlled substances.
- Coordination of controlled drugs destructions in accordance with DEA regulations.
- Maintain the confidentiality of pertinent information.
- Trend, prepare and present quality metrics to senior management.
- Other duties as assigned.
REQUIRED SKILLS AND QUALIFICATIONS
- Bachelor’s degree; 5+ years of dynamic Quality Assurance or Quality Control experience in the life sciences industry.
- Advanced knowledge GMP requirements.
- Understanding of Quality Systems pertaining to a bulk pharmaceutical, solid oral dosage manufacturing and packaging environment is preferred.
- Operational knowledge of European GMPs preferred.
- Must possess knowledge of DEA regulations and industry guidances, policies, and procedures pertaining to the DEA Controlled Substance.
- Excellent document quality.
- Ability to analyze and synthesize.
- Excellent interpersonal written and oral communication skills.
- Ability to coordinate, contribute to, and work within a cross-functional team.
Quality Specialist Job Roles in Pennsylvania
See all 114+ Quality Specialist Jobs in Pennsylvania
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Search Quality Specialist Jobs in PennsylvaniaQuality Specialist Jobs in Pennsylvania: Frequently Asked Questions
Which companies sponsor visas for quality specialists in Pennsylvania?
Pharmaceutical and medical device manufacturers lead visa sponsorship for quality specialists in Pennsylvania. Companies like Merck, GSK, Johnson & Johnson, and Siemens have documented sponsorship histories for quality-related roles. Food and beverage manufacturers in central Pennsylvania and defense contractors near Philadelphia also appear in Department of Labor disclosure data as sponsors for quality specialist positions.
Which visa types are most common for quality specialist roles in Pennsylvania?
The H-1B visa is the most common visa for quality specialists in Pennsylvania when the role requires a bachelor's degree in a specific field such as chemistry, engineering, or life sciences. Some positions qualify under the TN visa for Canadian and Mexican nationals if the role maps to an eligible TN occupation. Employers must file a Labor Condition Application with the Department of Labor before sponsoring any H-1B visa worker.
Which cities in Pennsylvania have the most quality specialist sponsorship jobs?
Philadelphia and its suburbs, particularly the Route 202 pharmaceutical corridor through Montgomery and Chester counties, concentrate the highest number of quality specialist sponsorship opportunities in Pennsylvania. Pittsburgh is a secondary hub, driven by healthcare, manufacturing, and robotics firms. Allentown and Reading also have active manufacturing bases where quality specialist roles with sponsorship occasionally appear.
How to find quality specialist visa sponsorship jobs in Pennsylvania?
Migrate Mate filters job listings specifically by visa sponsorship, so you can search quality specialist roles in Pennsylvania without sifting through positions that don't offer immigration support. The platform focuses on international candidates, which means listings are relevant to your situation. Filtering by Pennsylvania and the quality specialist role type will surface employers currently hiring and willing to sponsor.
Are there state-specific factors that affect quality specialist visa sponsorship in Pennsylvania?
Pennsylvania's concentration of FDA-regulated industries, particularly pharmaceuticals and medical devices, means quality specialist roles often require specialized credentials or experience that strengthens an H-1B specialty occupation determination. Penn State, Drexel, and the University of Pittsburgh generate a pipeline of international graduates in engineering and life sciences who pursue quality roles locally. Prevailing wage requirements are determined by the specific metropolitan area, so rates differ between Philadelphia and more rural parts of the state.
What is the prevailing wage for sponsored quality specialist jobs in Pennsylvania?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.