ANUJ JAIN

*** ********** *****, ****, ** *****

Cell: 858-***-****

E-Mail: adxqmi@r.postjobfree.com

EDUCATIONAL BACKGROUND

University of North Carolina, Greensboro, NC

B.S., Biology, 2007

For the past 15 years I have worked in the Quality Assurance field. I have extensive knowledge in GMP GLP, GCP, and GDP polices in the pharmaceutical and biotech industries. My expertise includes batch record review, authoring/editing SOPs, audits, protocols and other QMS reports. I also have worked in an FDA regulated environment particularly in as aseptic area of class 100, 10K, and 100K. Also, I have had interactions with FDA personnel and inspections. Highly trained and attention to detail have excelled my skills in all departments.

Expert communicator and presenter, fluent in English, with skill in building and maintaining long-lasting business relationships with sponsors, investigators, clinical staff, and C-Suite executives.

As of recently I have completed Six Sigma in white belt and yellow belt trainings. I have also started my real estate education in the beginning of the year 2021.

PROFESSIONAL EXPERIENCES

Accord Healthcare Inc Oct 2022 – Dec 2022

Sr. Associate QA

Review, monitor, quality release functions for third party commercial releases, which

includes review of change controls, deviations, OOSs and commercial batch records.

Ensuring third parties develop and track CAPAs against deviations and OOSs for

timely closure of the actions

Assist/coordinate Quarantine Release functions for Intas products

Assist/coordinate information collection from Quality/R&D teams for RFP questions from Sales Team

Manage SOPs/training/record keeping for Quality functions for commercial products

Manage Quality agreements/service agreements with distributors/service providers/REMS programs

Developing quality performance metrics with third parties and reviewing progress at

regular meetings

Johnson & Johnson Nov 2021 – Oct 2022

Batch Release Specialist

•Maintain oversight for status of individual batches, including all manufacturing process step start dates, sampling, testing, deviations, and release timelines

•Provide daily status updates of all batches on behalf of CMO/EQ team

•Update EM batch tracker and intake form (if applicable) at CMO daily with updated dates of process steps and investigations

•Oversee status of all open investigations, batch release timing, and communicate Quality project lifecycle for the COVID-19 Vaccine Quality function on behalf of the assigned CMO

•Collaborate with EQ team and CMO to ensure daily updates are accurate

•Conduct daily query of deviations and investigations at site

•Used computer program such as GLIMS, SAP, Oracle, to conduct investigations and risk assessments and gather all other documents for completes of batch records to shipment for clients for consumer commercial batches.

•Gather daily updates from EM site regarding deviations and investigations and work with Global Investigations team to ensure all Data Tracking Sheets are updated

•Communication when needed regarding alerts of any nonconforming results, out of trend, or out of specification results

•Understand risk and delays to batch release and communicate appropriately

Applied cGMP regulations and other FDA internal requirements to all aspects of products of drag substance and medial and final product disposition and tracking.

Quality oversight for drug product, drug substance, media preparation, and sterile supply

DAPNA Group Jan 2021 – Oct 2021

Quality Assurance Specialist

•Consulting with vendors and other large biotech and pharma companies for purchasing and perhaps sale of topical creams.

•Formulation and manufacturing products in a home-based environment.

•Revising and approving batch records and validation protocols and policies.

•Working with FDA for approval.

The AZZUR Group Aug 2020 – Nov 2020

Quality Assurance III

•Consulting with clients for proposed work regimes in the bio/pharmaceutical industry.

•Writing and approving biological investigations using a Trackwise system software.

Antech GLP Nov 2019 – Apr 2020

Quality Assurance Auditor

•Maintain knowledge of requirements for GLP compliance with FDA, EPA, OECD, Japanese Ministry of Health and other governmental regulations.

•Audit GLP studies for GLP compliance in timely manner.

•Review and provide comment on study documentation as needed, such as protocols, client site audit responses, CAPAs, Training Materials and SOPs.

•Conduct critical phase and in-process audits.

Panaceutics Inc Jun 2019 - October 2019

Quality Assurance Specialist

•Responsible for reviewing and authoring all SOPs, incoming batch records and intermediate records for production and shipment of final product

•Conducted internal audits of incoming material as well as production records and inventory of supplies necessary for production

•Created a database for all intermediate and production records from past and future batches to come.

•Conducted meetings with supervisors and management on progress and new innovation for better efficiency procedure.

•Trained new employees on GMP, and GDP practices.

Almac, Durham Oct 2018- Feb 2019

QC Inspector

•Reviews and input data into COSMOS and oracle data base for receipts of incoming goods.

•Inspect and follow up with clients and production teams with certain restrictions on the products for packaging and passing along to QA for release of products.

•Inspect incoming goods to ensure that clinical trial materials are acceptable for use in accordance with GMPs, Almac SOPs, and customer requirements.

•Inspect labeling and assembly operations to evaluate and monitor the quality of each batch independent from Production to ensure that operations are carried out in compliance with GMPs, Almac SOPs, and customer requirements.

•Inspect the processing of distribution orders, destined for a clinical site or depot, to ensure compliance with GMP/GDPs, Almac SOPs, distribution instructions, and customer requirements.

•Interacts with Quality, Operations, and Project Services personnel to report, address, and resolve quality issues.

Merck, Durham May 2016 – Oct 2017

QA Specialist

•Reviews all Critical Site Reports for accuracy and correctional data, editing GDP and GMP SOPS.

•Oversees the production floor on filling and labeling as well as compounding and production of batches and reviewing batch records, and looking for issues during production and assisting technicians in the cleanroom and making sure sterile processing is in accordance with FDA regulations.

•Reviews and responsible for collecting and analyzing documents to be processed by quality assurance personnel as well as production personnel.

•Works really close with operators and managers to determine any discrepancies in documents or product deviations to produce or come in contact with the batch.

•Analyze deviations, investigations, and issue CAPAs for improvement by personnel or other personnel.

•Train employees or other team members on technical equipment of current SOPs or updated SOPs to make sure colleagues are GMP compliant due to Merck’s status.

•Attends and conducts training pertaining to batch or other tasks as needed.

•Combines all documents needed for batch and fabricate binders to organize all batches by production schedule. Also update CSR calendar of all batches coming into production and arrange all PMS reports.

•Reviews and analyzes all personnel in regards to EM trends and involvement in production of batches.

•Responsible for imputing data into several computer-based applications, such as trackwise, LIMS, PMS and MIDAS. Also introduced to computer-based programs such as SAP, and COMET. MES applications (PAS-X)

•Analysis of data from microbiology tests, checking for excursions or discrepancy within the test or other facilities.

RegenMedTX TX, LLC/TwinCityBio Mar 2015 – May 2016

Quality Assurance Specialist

•Worked in an ISO 17025 accredited lab setting as well as other regulated environments, classes 100, 10K, and 100K clean room FDA regulated environments.

•Worked abs supervised sterile processing in a clean room environment, using sterile techniques inn mammalian cell culture, QC microbial tools and assays, as well as analytical techniques in a sterile processing room

•Also fully gowned in a sterile suit.

•Reviews all production protocols, SOPs, CCR’s, work request forms and deviations.

•Worked on numerous projects and managed personnel on project associated with clinical trials and manufacturing and distribution of medical devices and instruments.

•Author and execute qualification protocols, analyze data, and prepare summary reports

•Responsible for review process of batch records for accuracy and completion in order for shipment to client.

•Supervisor for GMP production team and cleaning personnel. Used QA principles and GMP and GDP practices to supervisor’s production aspects in a clean room environment.

•Responsible to relay information and products to clients for approval and order and handling of finished product.

•Validation and operation on many QC procedures as well as manufacturing processes.

•Investigating OOL and other procedures involving problems within the manufacturing and CPU areas of the lab.

• Reviews technical and quality system documents such as SOPs, Change Control and Deviation Reports, Batch Production Records, Technical Manuals, P&IDs, construction, as-built drawings, and flow diagrams as they relate to validation principles and regulatory compliance issues

•Making sure all manufacturing activities are GMP compliant and setting up manufacturing schedules for participating personnel.

•Ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections

•Establish an effective Quality Management System (QMS).

•Maintain a quality management system in accordance with FDA, Health Canada, and EU cGMP guidance

•Responsible for all inventory of all GMP instruments and material in the warehouse used for production.

•Review IQ, PQ and OQ documents and labels on equipment and logs used in production of finished goods and devices.

•Worked on implementing new ideas and plans for efficiency and readiness of product for shipment of client. Performed on site auditing of manufacturing plant.

•Perform internal and external audits for the company. Also, perform external audits of contracted vendors and other site vendors. regulations/guidelines, customer requirements, client SOPs and project specific guidelines/instructions.

•Inspection of incoming materials by vendors used for GMP purposes.

•Used microbiology applications for testing products coming in. Setup and operated LAL, bioburden and endotoxin samples for testing. Performed writing investigations on microbiology out of specification and implanted the root cause for these aspects.

•Also worked with the micro team to setup and inspect plated for micro-organisms and use plated for environmental monitoring of personnel and facility.

•Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures

• Makes decisions guided by policies and procedures that may impact the products quality, strength purity a potency of the drug substance. performance objectives.

• Consults on an as-needed basis with next level manager on more complex decisions.

• Worked on issuing and quality of instructional use and performance qualification and operational qualification on numerous sterile fill/finish machinery as autoclaves, lypholizers, BSC hoods, isolators and al other sterile instruments,

3D Consulting Nov 2014 - Mar 2015

Quality Assurance and Manufacturing Specialist

•Provide Quality services for GMP manufacturing of biologicals and devices to clients.

•Provide hands-on manufacturing support to clients.

Hospira Inc., Rocky Mount NC May 2014-Oct 2014

Biological Quality (BQ) Engineer

•Wrote excursion reports on parenteral reports of affected studies within the biological department using LIMS and Trackwise to analyze data.

•Organized the entire BQ library

•Documented and arranged all BQ batch records in respected departments.

•Validated quality assurance batches and reported to senior investigators.

ACell Inc., Columbia MD May 2013-July 2013

Quality Control Analyst

•Performed all production material testing using an Instron machine

•Performed all production testing for moisture analysis

•Worked with the R&D group on testing material for medical devices for use in clinical trials.

•Maintained compliance with GMP attributes and training.

•Ran ELISAs on product, testing for specific proteins on the collagen-based products.

•Trained on use of HPLC

•Coordinated with manufacturing teams in accordance with all training and in process checks on the floor as well in the clean rooms.

Pharmaceutics International Inc. (PII), Hunt Valley, MD Sept 2011-May 2013

Aseptic Manufacturing Associate/QA

•Performed fill-finish of vial and syringe-based drugs in a clean room environment.

•Worked on the clean room floor as a QA and manufacturing associate performing sterile filling and capping for fill finish products. Also, fully sterile gowning requirements were met according to FDA requirements.

•Performed final packaging of products for shipment to clients.

•Performed preparation of all aseptic and non-aseptic materials used for manufacturing of a batch, and including using part washers and manually cleaning.

•Provided assistance in compounding and filtration of the product for transfer into the clean room for aseptic manufacturing.

•Reviewed batch records and protocols used in manufacturing of products. Performed in process checks on vials or syringes after filling process and inspection procedures.

•Validated autoclaves, ovens, and other facilities within the aseptic department.

•Performed filter integrity tests on various products in the filtration process of production.

•Reviewed batch records for any deviations or CAPA processed during or after filling process.

•Also worked with the micro team to setup and inspect plated for micro-organisms and use plated for environmental monitoring of personnel and facility.

•Checked all incoming materials used for manufacturing and validated all products used for manufacturing.

•Inspecting IQ PQ and OQ on equipment’s used for production and analyzing trends for stability issues and validation studies. Setup calibration timelines for expertise personal come in for calibration.

Human Biosciences, Gaithersburg, MD Mar 2011-Sep 2011

Quality Assurance associate/QC Scientist

•Performed quality control testing of raw materials used in manufacturing of company products.

•Conducted review and audit of samples used for collagen-based products, as well as a supervisor in the manufacturing department of associates. Conducted review of all batch records and all CAPA documents.

•Performed documentation of all equipment and protocols used in the manufacturing.

•Organized all documentation used by the marketing group in the company.

•Supervised the production crew to make sure GMP and GDP practices were followed at all times.

•Worked with a team of associates to develop an impactful website for the business.

DG Bioactive, Inc., Winston Salem, NC May 2008–Aug 2010

Associate Scientist – Formulation/Quality

•Conducted formulation studies on new biologically active skin care products. Helped develop two new topical creams/lotions and demonstrated biological activity on skin fibroblast cells.

•Produced trial batches for new product lines.

•Performed QC testing on production runs in a GMP environment.

INTERSHIPS

Tengion, Inc., Winston Salem, NC (part-time) Aug 2006–May 2007

•Developed a method for trypsinizing primary cells using recombinant trypsin and compared it to porcine based trypsin.

•Assisted in the production and maintenance of primary smooth muscle and urothelial cells for use in the manufacture of neo-bladder constructs for Spina bifida patients.

•Worked on evaluation of the effect of cancer drugs on human bladder smooth muscle and urothelial cells. Information was used to design processes for obtaining cells from cancer patients for use in manufacture of regenerative medicine products.

•Performed protein extractions and protein analysis from cells and plasma specimens. Trained other associates in cell culture techniques, bioassays and laboratory protocols

Wake Forest Institute of Regenerative Medicine, Winston Salem, NC Summer 2005

Studied effects of drugs on bladder incontinence in animals over time. Study consisted of experiments in diabetic and normal rats with hypertensive bladders.

Smith & Nephew, San Diego, CA (Intern) summer 2004

Analyzed cells for viability using Guava technology. These cells were used to make tissue engineered human skin for treatment of diabetic foot ulcers.

PROFESSIONAL CERTIFICATIONS

Aseptic Gowning Certification – RegenMedTX, LLC 2014-2016

Aseptic Gowning Certification – PII 2011-2013

Aseptic Gowning Certification – Tengion Inc. 2008

GMP Documentation Recognition –Tengion Inc. 2006-2008

RELEVANT SKILLS

LABORATORY

Techniques and Specialized Equipment:

- Cell culture - Processing in BSC

- Aseptic technique - Palltronic Integrity tester

- Medium preparation - Osmometer, NOVA

- Cell cryopreservation - Controlled rate freezer, Lyophilizer

- Synthetic scaffold prep - Instron

GMP MANUFACTURING

- Aseptic Gowning - GMP equipment operation

- SOPs and Batch Records

- CSR Documents - Inventory maintenance

OTHER

- Proficient in Microsoft Office - Excellent oral, written

communication

- Accurate documentation, reporting - LIMS

-Trackwise/CAPA

- SAP - MIDAS

- Attention to detail - MES-PAX

- Six sigma (White Belt, And Yellow Belt)

- Lean manufacturing

- 5Why’s

- Root cause analysis - EMR

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