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GENERAL SUMMARY OF POSITION:

The QC Analyst I – Central Receiving is responsible for ensuring that the analysis of in process and finished formulation samples are performed according to standard operating procedures and cGMP / cGLP regulations. Maintains and trends results for Lot Release and Stability programs. Logs in samples for QC Central receiving. Performs final vial visual inspection for Quality Control. The position may require occasional weekend activities and travel to South Coast facility in Fall River, MA.

MAJOR RESPONSIBILITIES:

• Collect and process samples in a timely manner.
• Ensure samples are delivered to the appropriate laboratory in a timely manner. Assist in maintaining a sample schedule.
• Create and maintain QC master files for licensed MassBiologics and contracted products
• Log in and maintain in-process and final vial reserves
• Create stability summary tables and scan data to stability folder
• Create monthly visual inspection schedule for QC reserves.
• Perform final vial visual inspection activities for Quality Control.
• Enter and review data to be submitted for Quality Assurance review in a timely manner.
• Organize and compile data, assist in the analysis of data by statistical procedures as requested by Quality Control senior management.
• Generate, maintain and trend assay parameter data for designated assays.
• Participate in writing and revising SOPS, change controls and incident/deviation reports.
• Maintain log books related to inventory and equipment.
• Makes detailed observations in support of excursion investigations.
• Performs other additional job related duties as required

MINIMUM QUALIFICATIONS:

• Requires a Bachelor’s degree in Chemistry or related field with a minimum 0-2 years of relevant experience or equivalent
• Ability to follow instructions precisely , recognize deviations, and recommend corrective action within scope of training
• Ability to adapt to a cGxP regulated environment
• Ability to troubleshoot within scope of training
• Computer literate and proficient in MS Word, Excel and other relevant electronic systems.
• Strong 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 with others
• Demonstrated initiative through past experience
• Ability to work effectively both independently and as a member of a team