Quality Assurance Compliance Specialist

1 month ago

Allentown, United States Germer International - Pharmaceutical Recruiting Full time

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

  • Quality Assurance Compliance Specialist

    1 month ago

    Allentown, United States Germer International - Pharmaceutical Recruiting Full time

    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...

  • Senior Quality Assurance Specialist

    6 days ago

    Allentown, United States Germer International - Pharmaceutical Recruiting Full time

    Our 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

    6 days ago

    Allentown, United States Germer International - Pharmaceutical Recruiting Full time

    Our 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...

  • Transportation Quality Assurance Inspector

    3 weeks ago

    Allentown, United States Johnson, Mirmiran & Thompson Full time

    Transportation 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,...

  • Operations, Clinical Quality Assurance Specialist III

    4 weeks ago

    Allentown, Pennsylvania, United States Thermo Fisher Scientific Full time

    Work ScheduleFirst Shift (Days)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degrees, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job DescriptionWhen you are part of the team at Thermo Fisher Scientific, you'll do...

  • Transportation Quality Assurance Inspector

    3 weeks ago

    Allentown, United States Johnson, Mirmiran, and Thompson Inc. Full time

    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, 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...

  • Quality Assurance Inspector

    1 week ago

    Allentown, United States VeeRteq Solutions Inc. Full time

    Job DescriptionJob DescriptionTitle: Quality Assurance Inspector Location: Allentown, PA, 18106 Duration: 12 Months Job Type: Contract Work Type: Onsite Shift : Monday-Friday - 06.45 AM to 02.45 PMJob Description Our company seeks a Quality Assurance Inspector responsible for the quality of clinical products processed through primary and secondary...

  • Quality Assurance Supervisor

    6 days ago

    Allentown, United States Germer International - Pharmaceutical Recruiting Full time

    Quality Assurance Operations SupervisorAre you interested in working for a global, growing leader in anesthetic products? Our client is looking for a seasoned QA professional, that can manage a team of direct reports, as well as overseeing Quality Assurance Operations on the manufacturing floor.Essential Duties and Responsibilities Overall responsibility for...

  • Quality Assurance Inspector

    2 weeks ago

    Allentown, United States TekWissen LLC Full time

    Job DescriptionJob DescriptionOverview TekWissen Group is a workforce management provider throughout the USA and many other countries worldwide. The job opportunity below is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential...

  • Quality Assurance Inspector

    1 week ago

    Allentown, United States TekWissen ® Full time

    Position: Quality Assurance InspectorLocation: Allentown, PA, 18106Duration: 12 MonthsJob Type: ContractWork Type: OnsiteShift: Monday-Friday - 06.45 AM to 02.45 PMPay Rate: $26-$26/hrOverview TekWissen Group is a workforce management provider throughout the USA and many other countries worldwide. The job opportunity below is for one of our clients...

  • Transportation Quality Assurance Inspector Supervisor

    4 days ago

    Allentown, Pennsylvania, United States Johnson, Mirmiran & Thompson Full time

    Transportation Quality Assurance Inspector SupervisorLinkedIn Twitter Email Message ShareConstruction Management/Inspection - Transportatio Allentown, PA * ID: 21767* Full-Time/RegularJohnson, Mirmiran & Thompson is a dynamic, 100% employee-owned consulting firm of more than 2,300 professionals that provides a full range of multi-disciplined...

  • Transportation Quality Assurance Inspector Supervisor

    3 days ago

    Allentown, United States Johnson, Mirmiran & Thompson Full time

    Transportation Quality Assurance Inspector Supervisor LinkedIn Twitter Email Message Share Construction Management/Inspection - Transportatio Allentown, PA * ID: ...

  • Transportation Quality Assurance Inspector

    2 days ago

    Allentown, United States Johnson, Mirmiran, and Thompson Inc. Full time

    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, 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...

  • Quality Assurance Inspector

    2 days ago

    Allentown, United States Thermo Fisher Scientific Full time

    Work Schedule7 1/2 hr shiftEnvironmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degrees, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves,...

  • Quality Assurance Inspector

    1 week ago

    Allentown, United States Thermo Fisher Scientific Full time

    Work Schedule 7 1/2 hr shift Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degrees, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning,...

  • Quality Assurance Manager

    1 month ago

    Allentown, United States ForceBrands Full time

    **This is not a job at ForceBrands**Title: Quality Assurance ManagerPosition Location: Hybrid, max 3hr driving radius of Allentown, PA Position DescriptionThe Food Quality Assurance Manager supports efforts to safeguard brand integrity by maintaining and implementing diligent controls over established safety and quality programs. A significant portion of...

  • Quality Assurance Inspector

    2 weeks ago

    Allentown, United States Thermo Fisher Scientific Full time

    As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career...

  • Quality Assurance Inspector

    1 month ago

    Allentown, United States Thermo Fisher Scientific Full time

    As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals...

  • Quality Assurance Technician

    3 weeks ago

    Allentown, United States Patterns india Full time

    Job DescriptionJob DescriptionWe are looking for a detail-oriented QA Tech to oversee quality assurance processes, including micro testing and chemical analysis, ensuring adherence to GMP standards and maintaining the highest levels of product quality and safety.Location: Allentown, PA Duration: FulltimeQualifications: Requires a high school diploma...

  • Quality Assurance Technician

    4 weeks ago

    Allentown, United States Premium Waters Inc Full time

    Job Title: QA Technician Reports to: Quality Assurance SupervisorFLSA Status: Non-Exempt Shift: Days/NightsDepartment: Quality Assurance Prepared by: Human Resources Approved By: Plant Manager Date: July 29, 2024Qualifications: High School diploma or equivalent, undergraduate degree preferred Food, beverage, or liquid consumer product...