Quality Control Analyst II, Chemistry

Canton, MA

Job Req code: 761

Category: Quality Systems

We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others. Empowering Healing.

Organogenesis corporate headquarters is located in Canton, Massachusetts, and we have an additional site in Norwood, Massachusetts. Our Canton location is the manufacturing site for PuraPly® AM (which heals acute and chronic wounds), and Apligraf® (for the treatment of surgical wounds).  Our Norwood location manufactures ReNu® (offering regenerative and anti-inflammatory properties to create an environment that reduces pain) and NuCel® (which provides an enhanced environment for tissue growth, repair and healing). Canton is also the location for Customer Service, Reimbursement and other corporate teams, supporting our full range of products. 

The QC Analyst II is responsible for overseeing the implementation of the current Organogenesis quality system at the Canton, MA facility. The successful candidate will work closely with Sr. Level QC Engineers / Scientists / Analysts on ongoing projects in support of general quality activities and initiatives, product / process development, analytical support, pre-validation and validation activities, amongst other general duties routinely performed in the QC Chemistry Laboratory. The QC Analyst II will perform a variety of activities including but not limited to: the drafting of QC documents, drafting and execution of validation protocols, drafting and review of validation reports as well as ensuring that the transfer of OI systems are implemented in harmony with current OI practices. The successful candidate will use their existing skills in conducting routine and non-routine tests / experiments and provide support for the implementation of test methods (both routine and non-routine) for raw materials, excipients and final product. This position utilizes strong facilitation, problem solving, critical thinking and a can-do mind-set to ensure the implementation and continual improvement of quality systems and processes used to develop, manufacture and distribute safe and effective regenerative technologies that meet customer expectations and regulatory requirements.

Key Responsibilities:

  • Provide oversight to ongoing quality initiatives and projects including but not limited to:
  • The transfer of technology, documentation, policies and practices into the manufacturing facility.
  • Start-up and oversight of the QC Chemistry laboratory at the Canton facility.
  • Identification and incorporation of necessary QC equipment and instrumentation necessary to support day to day activities for the facility.
  • Implementation of OI’s visual inspection program for final product into the facility.
  • Design, qualification and implementation of mechanical and performing physical test methods such as Instron and Differential Scanning Calorimetry (DSC).
  • Assisting in the validation of new products, product line extensions, and new analytical methods.
  • Implementation and verification of USP test methods for the release of raw materials and excipients.
  • Responsible for the design, qualification and implementation of biological potency assays, ELISA’s and other plate-based methods for routine and non-routine use.
  • Overseeing the validation and testing of new processes, products and materials, product line extensions and analytical methods at the Canton facility.

 

 

Requirements

Physical Requirements:

This position requires 2 hours of standing per day (based on an eight-hour workday) with occasional stooping and lifting. This position also requires use of repetitive hand movement e.g. pipetting, preparing samples, testing samples, keyboard use, etc. for moderate or long periods of time.

Regulatory Requirements:

Fundamental knowledge of relevant Quality Systems and standard operating procedures. Fundamental knowledge of industry regulations and standards such as FDA, USP, and/or ISO. Basic understanding of industry trends.

System Requirements:

Fundamental working knowledge of tooling, test equipment, basic laboratory techniques, and good laboratory practices (CGLPs).  Microsoft Office including the use of Excel for basic statistical calculations.  Additional experience with other statistical based software a plus.  Experience with Bluehill’s Instron software a plus.

Preferred Education and Experience:

Graduate in the field of Chemistry, Bio-Medical Engineering or Biological Sciences, with a minimum of 3-5 years of related experience in a GMP/GLP regulated environment. Chemistry/Biology/Biomedical Engineering experience is highly preferred.