Current jobs related to Senior Quality Assurance Specialist - Allentown, Pennsylvania - Maxonic

  • Quality Assurance Specialist

    1 week ago

    Allentown, Pennsylvania, United States Central Admixture Pharmacy Services, Inc. Full time

    Job Title: Quality Assurance SpecialistCentral Admixture Pharmacy Services, Inc. is seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring site-specific quality compliance according to CAPS Standard Operating Procedures (SOPs) & specifications.Key Responsibilities:Perform product...

  • Quality Assurance Specialist

    1 week ago

    Allentown, Pennsylvania, United States Central Admixture Pharmacy Services, Inc. Full time

    Central Admixture Pharmacy Services, Inc.Job OverviewAt Central Admixture Pharmacy Services, Inc., we are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and safety of our pharmaceutical products. Your primary responsibilities will include...

  • Quality Assurance Specialist

    4 days ago

    Allentown, Pennsylvania, United States B. Braun Medical Inc Full time

    About the Role:B. Braun Medical Inc. is seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for reviewing and establishing quality standards for products and processes, identifying and mitigating quality risks, and conducting root cause analysis for defects and...

  • Quality Assurance Specialist

    1 week ago

    Allentown, Pennsylvania, United States Central Admixture Pharmacy Services, Inc. Full time

    Central Admixture Pharmacy Services, Inc.Job OverviewAt Central Admixture Pharmacy Services, Inc., we are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and safety of our pharmaceutical products. Key ResponsibilitiesDevelop and implement quality...

  • Quality Assurance Specialist

    4 weeks ago

    Allentown, Pennsylvania, United States LanceSoft Full time

    Job Title: Quality Assurance SpecialistWe are seeking a highly skilled Quality Assurance Specialist to join our team at LanceSoft. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of clinical products processed through primary and secondary packaging, warehouse, and distribution operations.Responsibilities:Apply Good...

  • Quality Assurance Specialist

    2 weeks ago

    Allentown, Pennsylvania, United States PeopleShare Full time

    Job Title: Quality Assurance SpecialistJob Summary: PeopleShare is seeking a Quality Assurance Specialist to join our team in the Lehigh Valley. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of pharmaceutical products and processes.Responsibilities:Preparation and review of SOPs related to warehouse and quality relevant...

  • Quality Assurance Specialist

    1 week ago

    Allentown, Pennsylvania, United States B. Braun Medical Inc Full time

    Job SummaryB. Braun Medical Inc. is seeking a Quality Assurance Specialist to join our team. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality in our products and processes.Key ResponsibilitiesDevelop and implement quality standards and procedures to ensure compliance with regulatory...

  • Quality Assurance Specialist

    1 week ago

    Allentown, Pennsylvania, United States Central Admixture Pharmacy Services, Inc. Full time

    Job SummaryCentral Admixture Pharmacy Services, Inc. is seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring site-specific quality compliance according to CAPS Standard Operating Procedures (SOPs) & specifications. This includes quality review of documents, label control, and...

  • Quality Assurance Specialist

    7 days ago

    Allentown, Pennsylvania, United States Central Admixture Pharmacy Services, Inc. Full time

    Central Admixture Pharmacy Services, Inc. is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring compliance with CAPS Standard Operating Procedures (SOPs) and specifications. Your duties will include quality review of documents, label control, and assisting with...

  • Quality Assurance Specialist

    1 week ago

    Allentown, Pennsylvania, United States Sharp Services Full time

    Job SummaryThe Quality Specialist plays a critical role in ensuring the quality of products and services at Sharp Commercial sites. This position requires a strong understanding of GMP guidelines and regulations, as well as excellent communication and problem-solving skills.Key ResponsibilitiesProvide quality oversight and guidance to designated functional...

  • Quality Assurance Specialist

    7 days ago

    Allentown, Pennsylvania, United States Central Admixture Pharmacy Services, Inc. Full time

    Job Summary:Central Admixture Pharmacy Services, Inc. is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring site-specific quality compliance according to CAPS Standard Operating Procedures (SOPs) & specifications. This includes quality review of documents, label...

  • Senior Quality Assurance Manager

    1 week ago

    Allentown, Pennsylvania, United States Central Admixture Pharmacy Services Full time

    Job SummaryCentral Admixture Pharmacy Services, Inc. is seeking a highly skilled Senior Quality Assurance Manager to join our team. As a key member of our quality team, you will be responsible for ensuring that our products and processes meet the highest standards of quality and regulatory compliance.Key ResponsibilitiesDevelop and implement quality...

  • Quality Assurance Specialist II

    2 weeks ago

    Allentown, Pennsylvania, United States B Braun Medical Full time

    Job Title: Quality Assurance Specialist IIB. Braun Medical, Inc. is seeking a highly skilled Quality Assurance Specialist II to join our team in Allentown, PA. As a key member of our quality team, you will be responsible for ensuring the efficient and effective operation of our quality management systems, ensuring compliance with regulatory requirements and...

  • Quality Assurance System Specialist

    2 weeks ago

    Allentown, Pennsylvania, United States Sharp Corporation Full time

    Job Title: Quality Assurance System SpecialistJob Summary:The Quality Assurance System Specialist provides quality oversight, guidance, and support to designated functional areas within Sharp Commercial sites. This role involves working closely with internal teams daily and representing Sharp Quality Systems in customer interactions. The Quality Assurance...

  • Quality Assurance Specialist

    1 week ago

    Allentown, Pennsylvania, United States Central Admixture Pharmacy Services, Inc. Full time

    Central Admixture Pharmacy Services, Inc.Job SummaryCentral Admixture Pharmacy Services, Inc. is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our sterile compounding operations. This includes performing product inspections, environmental...

  • Senior Quality Assurance Engineer

    2 weeks ago

    Allentown, Pennsylvania, United States DEW Softech, Inc Full time

    Job Title: Senior Quality Assurance EngineerLocation: Hybrid in Fort Lauderdale, FLJob Type: Full-timeAbout the Role:We are seeking a highly skilled Senior Quality Assurance Engineer to join our team at DEW Softech, Inc. This is a full-time, hybrid position in Fort Lauderdale, FL, requiring on-site presence three days a week.Key Responsibilities:Design and...

  • Quality Assurance Specialist

    1 week ago

    Allentown, Pennsylvania, United States Central Admixture Pharmacy Services, Inc. Full time

    Central Admixture Pharmacy Services, Inc.Job SummaryCentral Admixture Pharmacy Services, Inc. is seeking a Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring site-specific quality compliance according to CAPS Standard Operating Procedures (SOPs) and specifications. This includes quality review of...

  • Quality Assurance System Specialist

    1 week ago

    Allentown, Pennsylvania, United States Sharp Corporation Full time

    Job Summary:The Quality Assurance System Specialist provides quality oversight, guidance, and support to designated functional areas within Sharp Commercial sites. This role involves working closely with internal teams daily and representing Sharp Quality Systems in customer interactions. The Quality Assurance System Specialist is responsible for supporting,...

  • Quality Assurance Specialist

    1 week ago

    Allentown, Pennsylvania, United States Central Admixture Pharmacy Services, Inc. Full time

    Central Admixture Pharmacy Services, Inc.Job SummaryCentral Admixture Pharmacy Services, Inc. is seeking a Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring site-specific quality compliance according to CAPS Standard Operating Procedures (SOPs) & specifications. This includes quality review of documents,...

  • Senior Quality Assurance Director

    3 days ago

    Allentown, Pennsylvania, United States B. Braun Medical Inc Full time

    Company OverviewB. Braun Medical Inc is a leading medical device company committed to delivering innovative healthcare solutions.SalaryOur competitive salary for this role is approximately $113,000 per year, reflecting the importance of quality assurance in our organization.Job DescriptionAs a Senior Quality Assurance Director, you will be responsible for...

Senior Quality Assurance Specialist

2 months ago

Allentown, Pennsylvania, United States Maxonic Full time

Maxonic 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 and conversion to full-time)

Location: Remote

Compensation: Competitive hourly rate plus benefits

Work Schedule: Monday to Friday (40 hours/week)

Key Responsibilities:

Reporting to the Quality Manager for Documentation in PSG, this role is pivotal in supporting the Clinical Trial Division (CTD) through the review and approval of clinical and commercial batch records, both paper and electronic.

What You Will Do:

  • Uphold the principles of current Good Manufacturing Practices (cGMP) with an emphasis on patient safety while facilitating the swift introduction of products.
  • Leverage comprehensive knowledge of regulations, product authorizations, and manufacturing processes to meticulously verify all elements of batch safety, identity, strength, purity, and quality. Collaborate with clients to fully understand their batch review and release requirements along with the regulatory obligations they must meet.
  • Conduct thorough analyses of all inputs involved in the batch creation process, considering factors that may influence batch quality, such as environmental monitoring, analytical results, calibration, validation, and maintenance records.
  • Ensure that product batches failing to meet specified in-process and finished product standards are appropriately quarantined or rejected to prevent their use or release.
  • Engage with Operations, Quality Assurance (QA), and other internal teams to resolve batch release quality concerns or potential issues.
  • Proactively identify and communicate batch review concerns, escalating issues of non-compliance or Out-of-Specification (OOS) findings to Quality Management, and recommend solutions as necessary.
  • Prioritize batch record reviews and client releases to meet objectives and deliver high-quality results, maintaining a focus on both short-term and long-term operational goals.
  • Maintain exceptional internal and external customer service standards through clear and timely communication.
  • Promptly inform relevant internal parties of any delays.
  • Ensure that all provisions, including cumulative processing impacts, are thoroughly analyzed and satisfied before certifying finished goods batches for market release.
  • Represent QA and provide support in internal team meetings as required.

Qualifications:

  • A Bachelor's Degree is required (preferably in Life Sciences); an advanced degree is advantageous.
  • 3-5 years of experience in the pharmaceutical or medical device industry within a GMP environment, with a strong preference for candidates with 3 years of experience in finished goods commercial batch record release.
  • Detail-oriented with the ability to identify errors or deficiencies in batch records and apply sound judgment in assessing documentation accuracy.
  • Excellent communication skills, with the ability to engage effectively with colleagues at various levels of experience and management.
  • Familiarity with Quality Systems (change control, deviations, complaint management, eDMS), with knowledge of SAP, Trackwise, and Documentum being desirable.

About Maxonic:

Since 2002, Maxonic has been at the forefront of aligning candidate strengths with client challenges. Our award-winning team of specialized recruiting professionals excels in understanding technology needs and is committed to finding positions that align with the long-term career aspirations of our candidates. We take pride in our successful placements and the lasting relationships we build with our clients.