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Quality Assurance Chemist

2 months ago

Fall River, Massachusetts, United States Actalent Full time
Position Overview:
This role in Quality Control/Quality Assurance involves conducting routine analyses utilizing various chemical methodologies. The organization is seeking a candidate with substantial experience in the pharmaceutical sector who can integrate seamlessly and contribute positively from the outset.

Key Responsibilities:
  • Preparation, evaluation, and endorsement of specifications and procedures related to analytical processes.
  • Management of deviations, out-of-specifications, and out-of-trends, ensuring timely investigations and corrective actions in support of batch release.
  • Verification and assurance of compliance concerning packaging, raw materials, in-process, and finished product analytical documentation.
  • Oversight of lab equipment calibration and qualification documentation to ensure compliance.
  • Issuance and management of laboratory documents (Notebooks, Certificates of Analysis, etc.).
  • Maintenance of incoming documents with appropriate documentation and archival practices.
  • Execution of advanced and critical testing as required.
  • Operation of specialized equipment or execution of specialized skill testing.
  • Proficient use of instruments such as Karl Fischer, HPLC, GC, and particle size analyzers.
  • Adherence to all data integrity and cGMP practices and procedures.
  • Compliance with all good documentation practices.
Essential Skills:
Knowledge in capsules, pharmaceuticals, HPLC, SAP, raw materials, CAPA, SOPs, chemistry, quality control, analytical chemistry, GMP, and batch record review.

Qualifications:
  • Bachelor's degree in chemistry or a related field.
  • 3-5 years of experience in Quality Control or Analytical Quality Assurance.
  • 3-5 years of experience in a quality assurance role within a GMP pharmaceutical manufacturing environment.
  • 2-3 years of analytical chemistry experience utilizing HPLC, GC-MS, raw materials testing, and pH testing.
About Actalent:
Actalent is a global leader in engineering and sciences services and talent solutions, dedicated to helping innovative companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation, and speed to market. With a vast network of consultants and clients across multiple regions, Actalent serves many Fortune 500 companies.

Diversity, Equity & Inclusion:
At Actalent, we believe that diversity and inclusion are essential to the equity and success of our workforce. Our commitment to DE&I is reflected in our practices, including:
  • Recruiting diverse talent.
  • Fostering an inclusive environment through ongoing self-reflection.
  • Building a culture of care, engagement, and recognition with clear outcomes.
  • Providing growth opportunities for all employees.
Actalent is an equal opportunity employer and considers all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information, or any characteristic protected by law.