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Quality Control

1 month ago

Boston, United States Beacon Hill Full time

Beacon Hill Life Sciences has a great opportunity available for a QC Biologics Analyst with GMP experience to work a contract assignment located in Boston/Mattapan, MA.


Duration of contract assignment is at least 6 months. Will be responsible for quality control of biological assays, performing cell culture/harvesting. Start date of assignment will be mid to late August. Work schedule is full-time, M-F, 40 hours/week. Pay Rate is based on experience with range of $40 - $50/hour.


The QC Analyst is responsible for supervising and conducting routine and non-routine analysis of in process and finished formulations according to standard operating procedures. Compiles data for documentation of test procedures and prepares reports. Calibrates and maintains lab equipment. May develop testing methods. Reviews data obtained for compliance to specifications and reports abnormalities. Revises and updates standard operating procedures as needed. May perform special projects on analytical and instrument problem solving. Applies knowledge of good manufacturing practices and good laboratory practices on a daily basis.


Skills Required:

· qPCR

· ddPCR

· ELISA (Competitive)

· ELISA (Sandwich; microplate based)

· Dynamic Light Scattering

· TCID50

· DNA Extraction

· Buffer Preparation

· Cell Culture

· Cell Harvesting


Responsibilities:

  • Conducts laboratory testing on in-process, bulk and final vial samples as set forth in SOPs
  • Performs review and sign-off of assays, adhering to cGMP and cGLP regulations
  • Able to works on problems of diverse scope requiring evaluation of situations or data to identify relevant factors
  • Maintains reagent, orders supplies and cleans laboratory areas, hoods and common equipment
  • Organizes and compiles data and assist in the analysis of data using various procedures
  • Generates, maintains and trends assay parameters
  • Takes initiative in solving technical problems that arise
  • Troubleshoots assay and instrumental problems within scope of experience
  • Participates in writing and revising SOPs, change controls and incident/deviation reports.
  • Performs annual review of SOPs.
  • Assists in the development and optimization of testing methods.
  • Assists in the qualification of new controls, standards and reagents
  • Maintains log books related to inventory and equipment.
  • Ensures labs are clean, safe (in compliance with cGMP) and properly stocked
  • Makes detailed observations, analyzes data and interprets results
  • Participates in writing technical reports, data summaries or protocols
  • Performs other additional job related duties as required


Qualifications:

  • Minimum of 3-7 years of relevant experience or equivalent
  • Ability to follow instructions precisely, recognize deviations, and recommend corrective action
  • Prior experience in a cGxP regulated environment. Strong working knowledge of cGLP and cGMP regulations.
  • Demonstrated ability to train and supervise others
  • Ability to conduct complex troubleshooting
  • Computer literate and proficient in MS Word, Excel and other relevant electronic systems
  • Strong critical thinking, time management and organizational skills. Demonstrated ability to multitask and consistently meet deadlines
  • Possesses well developed attention to detail, ability to maintain accurate records and excellent proofreading skills.
  • Excellent written and verbal communication skills. Ability to communicate effectively (up, down, and laterally) with others
  • Demonstrated initiative through past experience
  • Requires ability to work flexible, and, at times, extended work hours to meet business needs
  • Ability to work effectively both independently and as a member of a team


Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.


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