QC Analyst II/III - Analytical

JOB SUMMARY

The QC Analyst II/III will be responsible for routine and non-routine QC testing according to Standard Operating Procedures (SOPs) in a GMP laboratory.  This position is based at Genezen’s state-of-the-art facility in Lexington, MA.  This role supports the daily and occasional 2nd shift or weekend operations within the Quality Control group via execution of analytical testing and Quality Systems.  This includes but is not limited to in-process, release, and stability testing.  Execution of quality systems entails deviations, corrective and preventive actions (CAPAs), investigations, Out of Specifications (OOS), and change controls.  These activities are all performed in accordance with cGMP guidelines and are supported by departmental and inter-departmental policies and standard operating procedures.

ESSENTIAL JOB FUNCTIONS

• Perform routine/non-routine testing and review of in-process, DS and DP release and stability samples in accordance with Standard Operating Procedures (q-PCR, HPLC (SEC, IEX, rpHPLC), ELISA, RI, HIAC, DLS, Osmolality, Western Blot, CE-SDS, etc.)
• Performs peer review as SME of assay data with minimal errors.
• Able to work effectively in internal/cross-functional teams as an active member.
• Train and execute assays cross-functionally to support deadlines for release.
• Participate in equipment validation, method transfer/qualification/validation, critical reagent qualification and special protocol execution as required.
• Responsible for protocol and report generation/revision/review, as required.
• Strong understanding of regulations, able to apply to any situation, and identify deficiencies w/ some guidance.
• Establish, revise, review and maintain standard operating procedures.
• Responsible for Quality Systems related to QC Operations such as identifying a deviation to procedure, perform investigation, Change Controls, CAPAs, OOSs, OOTs.
• Promptly and proactively communicates gaps to key stakeholders and recommends solution w/minimal guidance.
• Responsible for protocol and report generation/revision/review, as required.
• Strong understanding of regulations, able to apply to any situation, and identify deficiencies w/ some guidance.
• Promptly and proactively communicates gaps to key stakeholders and recommends solution w/minimal guidance.
• Supports internal and external audits as required

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Flexibility to support 2^nd shift STAT testing as required on a monthly rotational basis. May include holidays.
• Criminal background check required.
• Other duties as assigned

EDUCATION/CERTIFICATION/LICENSES

• BA or BS in Chemistry/Biochemistry or other related science

ON THE JOB EXPERIENCE

• Minimum 2-5+ years (Analyst II) and 5–8+ (Analyst III) of laboratory base experience within QC testing capacity, preferably in cGMP environment.

• High proficiency in HPLC methods and analysis, as well as other analytical methods.

• Follow procedures trained on and complete documentation applying cGMP/GDP/ALCOA+.

• Thorough understanding of industry testing requirements/standards

SKILLS/ABILITIES

• Computer literacy (MS Word, Excel, and LIMS)

• Good/effective communication, organizational, and critical thinking skills with the ability to work well with others and independently

• Identify gaps and propose solutions.

PAY RANGE

The annual salary range for this position is $80,000-$100,000.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Regularly sit for long periods of time

Movement

• Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 10 pounds
• Rarely lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail