QA Specialist - 1205567

at Apex Systems, Inc in NEW CASTLE, Delaware, United States

Job Description


Apex Systems has an immediate opening for a QA Specialist! this is a great opportunity to be involed in all areas of QA with a growing company.

Position Summary:

This position will provide day-to-day quality assurance support to Quality Assurance and cross-functional teams, including Manufacturing, Process Development, R & R&D Chemistry, Analytical/QC, Facility, shipping/receiving, EHS, and Project Management to ensure continuous manufacturing, testing, release, and shipment of products to our clients. As a QA Specialist, you will maintain and improve the effectiveness of QMS by using quality policies, procedures, ISO 9001 and other applicable regulations, audit results and analysis of data, and corrective & preventive actions.

Responsibilities and Duties include:

  • Drafts, reviews, revises, approves, and authorizes procedures, work instructions, protocols, validations, specifications, and qualifications.
  • Provide day- to- day quality floor support over manufacturing, testing, and release of raw materials, intermediates, and final products.
  • Performs review of batch record, and associated manufacturing & testing document, Certificate of Analysis (CoA), equipment binder/logbook, lab notebook, to support product disposition.
  • Identify Quality issues, and resolve them in a diplomatic, flexible, and constructive manner.
  • Prepares/ issues the BMR and relevant manufacturing/testing documents, laboratories notebook, investigation number, change control, audit report, number equipment logbook number.
  • Maintain SOP Master List, and other manufacturing document master list and update, as necessary.
  • Initiates/reviews change control, investigation/Deviations and CAPA, and authorize/approve the investigation/CAPA and change control.
  • Investigates non-conformances/OOS/OOT investigations pertaining to the manufacturing and testing of pharmaceutical and OLED products.
  • Conducts/leads the internal audit to our QMS/process (Chemistry, manufacturing, analytical laboratories, facility, critical material suppliers), and writes/issues audit report and share the report with the QA and the management to support continuous improvement.
  • Facilitates/ supports customer audit, ISO/3rd party audit and regulatory audit, and preparing the response to address audit findings/CAPA.
  • Provides employee training & track training and manages employee training records.
  • Monitors supplier management systems and ensures compliance and accuracy.
  • Support customer complaints, inquiries, specification reviews, and their questionnaires.
  • Stores/manages and archives all controlled documents internally and externally relevant to QMS, manufacturing, testing, shipping, equipment qualification, calibration, and maintenance binder.

Education and Experience:

Minimum of bachelors or higher degree with Chemistry/Chemical engineering or science field3-10 years of experience in a cGMP/ICH/highly regulated QA/QC within manufacturing environment QA.

Thorough expertise on ISO 9001, cGMP, ICH Q7, eQMS in pharma or chemical regulated environments is a plus.

  • Professional certification such as CQA, Six Sigma, CQM, CQA, CQE is a plus

Communication, Analytical and Organization Skills:

  • Must have excellent written and oral communication skills with technical writing /review skills.
  • Should have strong organizational, analytical skills and the ability to work with the internal and external stakeholders and customers.
  • Excellent problem-solving skills and experience with root cause investigations and CAPA determination

Computer Skills:

  • Proficient with Microsoft Office/visio/MS Outlook/Team and Zoom.
  • Must be proficient in data entry, data analysis/processing, presentations, and calculations.

Mathematic Skills:

  • Calculate figures and amounts such as proportions, percentages, area, circumference, and volume.
  • Apply concepts of basic algebra and geometry, fractions, ratios, and proportions to practical situations.
  • Utilize statistical analysis for trending data and apply outcomes to process improvements.

Benefits Package:

Our highly competitive employee package offers medical, dental and vision benefits 100% employer paid. Also included are:

  • 401K Plan
  • Employee Stock Purchase Plan
  • Life, Disability and AD&D Insurance
  • A generous time-off policy that includes up to twelve weeks of maternity/parental leave

We want you to start with us and retire with us.

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or 844-463-6178.

VEVRAA Federal Contractor We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state. We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available here.
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Job Posting: 875656

Posted On: Nov 21, 2021

Updated On: Dec 21, 2021