Current jobs related to Quality Assurance Compliance Specialist - Allentown - Germer International - Pharmaceutical Recruiting
-
Quality Assurance Specialist III
1 week ago
Allentown, Pennsylvania, United States Integrated Resources, Inc Full timeJob OverviewPosition Title: Quality Assurance Specialist IIICompany: Integrated Resources, IncJob Summary:This role is integral to the Quality Assurance team, focusing on the evaluation and approval of clinical and commercial documentation. The Quality Assurance Specialist III will ensure compliance with regulatory standards while supporting the Clinical...
-
Quality Assurance Specialist
1 week ago
Allentown, Pennsylvania, United States Keurig Dr Pepper Full timePosition Overview:The Quality Assurance Specialist plays a vital role in collaborating with Quality, Operations, and Maintenance teams to execute validation and verification tasks during shifts. This position is essential for upholding the Food Safety Management System as required.Shift & Schedule:This is a full-time role on the Night Shift, following a...
-
Senior Quality Assurance Specialist
1 week ago
Allentown, Pennsylvania, United States Maxonic Full timeMaxonic is dedicated to fostering a strong and enduring partnership with our esteemed client. To meet their requirements, we are seeking a Quality Assurance Specialist III (Medical Device & Manufacturing).Position Overview: Job Title: Quality Assurance Specialist III (Medical Device & Manufacturing)Job Type: Long-term Contract (with potential for extension...
-
Allentown, Pennsylvania, United States AlphaGraphics - US207 Full timeJob OverviewThe Quality Assurance Specialist plays a crucial role in ensuring that all products meet consumer expectations. This position involves a thorough examination of production processes to guarantee adherence to quality standards and the assessment of final products post-production.Key Responsibilities:Establish acceptable variation ranges for...
-
Quality Assurance Specialist, Shipping
2 days ago
Allentown, Pennsylvania, United States AlphaGraphics - US207 Full timeJob OverviewThe Quality Assurance Specialist plays a crucial role in ensuring that products meet consumer expectations. This position involves examining production jobs to verify compliance with quality standards and assessing the final output after manufacturing.Key Responsibilities:Establish acceptable variation ranges for production jobs and identify...
-
Senior Quality Assurance Specialist
3 weeks ago
Allentown, United States Germer International - Pharmaceutical Recruiting Full timeOur well estblished pharmaceutical client is looking for a Senior Quality Specialist to join their growing team. Our client is looking for someone to be apart of their crucial success where your contributions and expertise will make a significant impact.Essential Duties and ResponsibilitiesResponsible for the review, approval, and disposition of finished...
-
Senior Quality Assurance Specialist
3 weeks ago
Allentown, United States Germer International - Pharmaceutical Recruiting Full timeOur well estblished pharmaceutical client is looking for a Senior Quality Specialist to join their growing team. Our client is looking for someone to be apart of their crucial success where your contributions and expertise will make a significant impact.Essential Duties and ResponsibilitiesResponsible for the review, approval, and disposition of finished...
-
Quality Control Specialist
1 week ago
Allentown, Pennsylvania, United States Patterns india Full timeJob OverviewWe are seeking a meticulous Quality Control Specialist to manage quality assurance activities, encompassing microbiological testing and chemical evaluations, while ensuring compliance with Good Manufacturing Practices (GMP) and upholding the utmost standards of product excellence and safety.Position Details: This is a full-time role based in a...
-
Quality Assurance Specialist
7 days ago
Allentown, Pennsylvania, United States TekWissen LLC Full timeJob DescriptionOverview: TekWissen Group is a leading provider of workforce management solutions across the USA and internationally. We are currently seeking a Quality Control Inspector for our client, a prominent player in the biotechnology sector, focused on product development services. This organization is committed to delivering essential laboratory...
-
Lead Quality Assurance Analyst
2 days ago
Allentown, Pennsylvania, United States Germer International - Pharmaceutical Recruiting Full timeOverviewGermer International - Pharmaceutical Recruiting is seeking a highly skilled Senior Quality Assurance Specialist to enhance our client's established pharmaceutical operations. This role is pivotal in ensuring the quality and compliance of products, contributing significantly to the overall success of the organization.Key ResponsibilitiesOversee the...
-
Quality Assurance Specialist
7 days ago
Allentown, Pennsylvania, United States TekWissen ® Full timePosition: Quality Control InspectorLocation: Allentown, PADuration: 12 MonthsJob Type: ContractWork Type: OnsiteShift Timings: Monday-Friday - 03:15 PM to 11:15 PMPay Rate: $26-$26 per hourCompany Overview: TekWissen Group is a prominent workforce management provider, recognized for its expertise in biotechnology product development services. Our client is a...
-
Transportation Quality Assurance Inspector
1 month ago
Allentown, United States Johnson, Mirmiran & Thompson Full timeTransportation Quality Assurance Inspector LinkedIn Twitter Email Message Share Construction Management/Inspection - Transportatio Allentown, PA * ID: 21225 * Full-Time/Regular Johnson, Mirmiran & Thompson is a dynamic, 100% employee-owned consulting firm of more than 2,300 professionals that provides a full range of multi-disciplined engineering,...
-
Transportation Quality Assurance Inspector
1 week ago
Allentown, United States Johnson, Mirmiran & Thompson Full timeTransportation Quality Assurance Inspector LinkedIn Twitter Email Message Share Construction Management/Inspection - Transportatio Allentown, PA * ID: 21766 * Full-Time/Regular Johnson, Mirmiran & Thompson is a dynamic, 100% employee-owned consulting firm of more than 2,300 professionals that provides a full range of multi-disciplined engineering,...
-
Lead Quality Assurance Expert
2 days ago
Allentown, Pennsylvania, United States Germer International - Pharmaceutical Recruiting Full timeOverviewGermer International - Pharmaceutical Recruiting is seeking a highly skilled Senior Quality Assurance Specialist to enhance the quality assurance processes within a prominent pharmaceutical organization. This role is pivotal in ensuring that quality standards are met and maintained throughout the production cycle.Key ResponsibilitiesOversee the...
-
Quality Assurance Inspector
13 hours ago
Allentown, United States Careers Integrated Resources Inc Full timeJob Title: Quality Assurance Inspector Job Location: Allentown, PA Job Duration: 12 months (possibility of extension) Shift: Mon. to Fri. 6:45 am - 2:45 pm Payrate: $25.90/Hour Job Responsibilities Responsible for the quality of clinical products processed through primary and secondary packaging, warehouse, and distribution...
-
Transportation Quality Assurance Inspector
1 month ago
Allentown, United States Johnson, Mirmiran, and Thompson Inc. Full timeJohnson, Mirmiran & Thompson is a dynamic, 100% employee-owned consulting firm of more than 2,300 professionals that provides a full range of multi-disciplined engineering, architecture, information technology, and related services to public agencies and private clients throughout the United States. JMT is currently ranked #61 on Engineering News-Record’s...
-
Clinical Quality Assurance Specialist
1 week ago
Allentown, Pennsylvania, United States Thermo Fisher Scientific Full timeWork ScheduleEnvironmental ConditionsJob OverviewAt Thermo Fisher Scientific, you will engage in impactful work that contributes positively on a global scale. Join our dedicated team in fulfilling our Mission daily, empowering our clients to enhance global health, cleanliness, and safety. We equip our international teams with the necessary resources to reach...
-
Lead Quality Assurance Analyst
7 days ago
Allentown, Pennsylvania, United States Germer International - Pharmaceutical Recruiting Full timeOverviewGermer International - Pharmaceutical Recruiting is seeking a highly skilled Senior Quality Assurance Specialist to contribute to the success of a well-established pharmaceutical organization. This role is pivotal in ensuring that quality standards are met and maintained throughout the production process.Key ResponsibilitiesOversee the evaluation,...
-
Lead Quality Assurance Analyst
3 days ago
Allentown, Pennsylvania, United States Germer International - Pharmaceutical Recruiting Full timeOverviewGermer International - Pharmaceutical Recruiting is seeking a highly skilled Senior Quality Assurance Specialist to contribute to the success of a prominent pharmaceutical organization. This role is pivotal in ensuring that quality standards are met and maintained throughout the production process.Key ResponsibilitiesOversee the evaluation,...
-
Lead Quality Assurance Analyst
1 week ago
Allentown, Pennsylvania, United States Germer International - Pharmaceutical Recruiting Full timeOverviewGermer International - Pharmaceutical Recruiting is seeking a highly skilled Senior Quality Assurance Specialist to enhance our client's reputable pharmaceutical organization. This role is pivotal in ensuring that quality standards are met and maintained, contributing significantly to the overall success of the company.Key ResponsibilitiesOversee the...
Quality Assurance Compliance Specialist
2 months ago
Quality Assurance Compliance Specialist
Are you looking for a role that will allow you to gain exposure and experience in various aspects of Quality Assurance? This role will be gain experience working with document control review, batch record review, as well as participating in audits.
Our client, a global leader in the development and manufacturing of inhaled anesthetics, is looking for a Quality Assurance Compliance Specialist to join their growing team and help support the manufacturing of their diverse commercial portfolio, while reporting to the Associate Director of Quality Assurance.
Essential Duties and Responsibilities
- Packaging Batch Records: Reviews final batch records on paper and electronically, documents batch errors from various departments, tracks, and issues reports.
- Manufacturing Batch Records: issues batch records to production, electronically review production batch records, file and archive all the completed physical records.
- Review lab data on paper/electronically for inclusion on C of A
- Responsible for certificate of acceptance (C of A) generation for Bulk and Finished drug product, coordination of finished batch status tracking
- Releases product within SAP and generates reports as needed
- Reviews calibration sheets.
- Supports the quality document archive system
- Assist in the activities related to document control when needed
- Act as a backup to other QA associates in his/her absence
- Performs and supports internal audits and regulatory agency audits as needed
- Performs special projects as directed by Quality Assurance management
- Trains new employees in the department on the various tasks
- Supports launch of new products in auditing/ understanding new processes as needed
- Assist with reviews and investigations for Deviations
- Assist with and/or conduct APRs
- Assist with and/or conduct the updating of CRNs
- Produce logbooks as requested
- Supports RA requests relative to filings and submissions
- Support Packaging Line Inspector including coverage as needed
- Assist with and/or conduct BOM and MBR updates
Key Competencies (knowledge, skills and abilities every person must possess to be successful)
- Critical Thinking — using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems
- Excellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customers
- Excellent verbal and written communication skills
- Creative and able to present various solutions
- Energetic, enthusiastic and motivational disposition
- Maintain confidentiality
- Coaching skills
QUALIFICATIONS
Education/Experience
- Minimum of 4-year degree in science or technical field, preferably Chemistry or similar discipline (or combination of equivalent experience) preferred
- Minimum of 5 years’ experience in a regulated industry; Pharmaceutical or Medical device
- Knowledge of FDA, GMPs, GDPs, GLPs and Quality Assurance/Quality Control skills required
- Understanding of quality systems and processes
- Excellent verbal and written communication skills
- Experience with Microsoft Office applications and Trackwise systems (SAP and EDMS experience a plus)
- Experience within a manufacturing and/or packaging environment
- Demonstrated ability for effective communication, teamwork, and problem solving skills
