Quality Associate Resume

SUMMARY:

Quality Assurance Professional with extensive pharmaceutical industry experience. Proven abilities in batch record review/disposition and Manufacturing Investigations with the ability to function independently and exercise judgment and leadership in accordance with objective legal and regulatory requirements, under complex and demanding circumstances.

PROFESSIONAL EXPERIENCE:

QA Validation Associate, Confidential, Allendale, NJ (Sep’11-Present)

Create/Issue batch records/labels required for processing based on production schedule.
Provide QA Line clearance prior to the start of client processes.
Worked on IQ/OQ/PQ review them and assist in Protocol making and reviewing them.
Ensure complete and thorough review/closure of all production batch records for completeness, accuracy and compliance with company and regulatory policies.
Collaborate with Materials management to ensure the proper inspection/testing and disposition of all materials required for processing by analyzing sterility, compliance and/or quality data.
Participate in weekly deviation and corrective action (CAPA) meetings to ensure that all investigations are completed in a timely and compliant manner.
Update and revise Standard Operating Procedure’s (SOP’s) as necessary according to cGMP, cGLP guidelines.
Assist and participate in regulatory audit inspections by providing procedures, documents and responses to auditors.
Review/Maintain all Environmental data, Validation Protocol and reports to ensure personnel and equipment is within required specification.

QA Associate, Confidential,Morris plains ,NJ (May’11-Sep’11)

Responsible for compliance review and approval of intermediate batch records related to batch disposition..
Assist product complaint follow-up. discrepancy reporting, investigations and CAPAs associated with incoming, in process and production batch processing.
Investigating QA Deviation.
Working on ORACLE, Excel, Microsoft Outlook to make MBR.
Supporting electronic management system.

QA Associate, Confidential,South Plainfield, NJ (Feb’10-March’11)

Sample and inspect raw materials, in-process and finished goods, packaging and labeling.
Inspect, clear and release manufacturing rooms and packaging lines.
Maintenance of BMR.
Assisting in non-conformance and investigation.
Document procedures, record data and review records for completeness and accuracy to ensure compliance with SOP\'s and GMP\'s.
Train and mentor new Quality Assurance Inspectors.

Aseptic Associate, Confidential,Lakewood, NJ (sep’10-Nov’10)

Filling and sealing of vials.
Environmental Monitoring, Water Sampling.
Operate line equipment to meet product specifications.
Weight checks and batch record maintenance.
Class 100 to 100,000 gowning experience.
Documentation and Maintaining logbook by following SOP and cGMP.
Performing inspection during vial filling.

Quality Associate, Confidential,Ahmadabad, India (Jan-’06- Dec ’07)

Updating SOPs and assisted in regulatory documentation
BMR Records maintenance.
Assisting quality compliance issue.
Assure the Quality of packaging products.

Analyzed raw material, in process and finished product specification as per SOP.
Assisting in internal audit.

EDUCATION:

MS in Pharmaceutical Manufacturing,

Bachelor of Pharmacy

SKILLS:

Good understanding of cGMP, Good communication and interpersonal skills, FDA/DEA knowledge.

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