Connie Marie Lemken

442-***-****

ady9ly@r.postjobfree.com

Professional Summary

I possess 30 years of experience as Configuration Management/Document Control Analyst/QA Specialist. Experience in cGMP environment. I work well in a team driven atmosphere and I am flexible to changing environments. I possess a strong work ethic and a desire for exceptional results. I believe my background uniquely qualifies me to become an integral and valuable member of any team. I have the ability to work independently and creatively with the maturity necessary to complete high-pressured jobs correctly and on time. Strong understanding of Document Control requirements and processes. I am interested in utilizing theses strong skills in a challenging and rewarding career opportunity with successful and diversified organization.

Work Experience

STA Pharmaceutical US LLC, A WuXi AppTec Company, San Diego, Ca 10/30/2017 - 4/4/2023

Sr. QA Specialist/Lead Document control specialist

Responsible for managing all cGMP controlled documents and records .Shipping and receiving raw materials. Batch record reviews. Process all Document Control Requests (DCR’s), route and track the document review, approval and distribution. Audits, Line clearance, Master Batch records, EBR’s Training new employees. Recruiting new vendors. Method validation reviews, calibration verification in all cleanrooms equipment’s. Experience in cGMP environment. Review document drafts for grammar, spelling and formatting and making corrections as needed for making documents effective for use. AVL management. Assist QA director on validation reports,CAPA and deviations. Questionnaire Forms for Material Supplier and follow-up for completion. Line Clearance, Master batch records and Executed batch records.Organize and maintain filling electronic systems and paper based. GMP controlled documents such as SOPs (Standard Operating Procedures), Master batch records, QC test data, weekly monitoring charts, memos, policies, and training records. Interacting with cross-functional groups such as Quality Control, Regulatory Affairs, Clinical, Chemical Development, Chemical Engineering, and Material Management. Lab notebooks review. Assign batch numbers, deviation, non-conformance, OOS, CAPA and material specification numbers and maintain a log of each for completion within a specified time frame. Responsible for planning of internal audits, supplier audits and regulatory audits to ensure compliance current practices. Ensure traceability of material and parts. QA Supervisor of Line Clearance inspection of material before production and shipments. Responsible with off-site document archival per company policies. Detail oriented, proactive, works independently, works well with others. Manage corrective action and quality improvement activities.

Breg, Carlsbad, California 10/2014 –09/2017

Sr. Document Control Analyst

BRACING AND COLD THERAPY

Document Control Specialist is responsible for administering the Quality System controlled documents in accordance with Breg’s policies and procedures and Ensures compliance with all relevant ISO and FDA GMP regulatory requirements (e.g., ISO 13485, 21 CFR 820).

Administration of ECOs and the document change control process including the review of Documentation, reading engineering drawings and BOM Structures for completeness and correctness as well as Change Notice submissions for acceptability prior to signature routing as you ensure proper distribution and retrieval of controlled documents. Ensure training requirements are addressed and documented when required as well as supporting quality engineering, quality control activities.Release Engineering Change Orders (ECOs) by ensuring the request meets the Change Control policies, procedures and regulation standards.

Coordinate and perform training for all new employees and users on the change control process as required. Responsible for maintaining the Engineering Change Order log from start to release and develop monthly measurement to be used for process improvements. Recruiting new vendors.Facilitate the Change Control Board.Generate notifications to the appropriate process owners and authors on new or revised documents. Act as the liaison between Mexicali and Vista on shared activities. Assist in internal process development focused on streamlining Change Order efficiency and effectiveness through continuous improvement tools. Lead effective team meetings and document results. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.Configuration Control Essential Duties: Perform data entries to Bill of Materials, Item Master, and Change Orders and Approved Vendor List. Essential Duties: Responsible for creating and updating the Standard Operating Procedures (SOP) and forms, and ensuring the SOPs conform to established document formats and applicable standards. Maintain the employee training records, department matrixes and enter the information. Responsible for Internal Audits.Participates in analyzing and reviewing changes with engineering, quality assurance and manufacturing to determine overall effect of changes on product or system and to ensure compliance with customer requirements and Company policy.

ViaSat, Carlsbad, California 02/2013 – 06/2014

Government Contracts/Configuration Management/Document Control Specialist

SATALITE COMMUNICATIONS

Responsible for multiple government programs and Contracts (secret clearance).

document control and track all ECR’s, ECO’s Deviations in Oracle Agile. Review Change orders for completeness, accuracy of documents. Recruiting new vendors. Review for completeness of government contracts. Responsible for logging, filing, and tracking all necessary drawings, documents, and government contracts in Agile. Secret clearance. Inventory Library Assessment for the entire company. CDRLS.Compile and summarize data to use in preparing special reports maintain data deliverable schedules, and post data items to customer websites and generation/editing, completion, processing, and release of documents, change orders, change proposals, and data packages.

Became a super user in the corporate Product Lifecycle Management (Oracle/Agile) tool.

Linear LLC, Carlsbad, California 01/2006– 01/2013

Sr. Document Control Analyst/Lead role

SECURITY AND CONTROL PANELS/GARAGE DOORS

Responsible for documenting and tracking all new/existing documents in the Maxcim database, and all aspects of ECO’s (Engineering Change Orders). Linear uses a Manufacturing Resource Planning (MRP) which stores part numbers in a database. Supervised employees on systems.

These part numbers are controlled and maintained by Document Control changes to established master files of contractually requires technical data. Responsible for generation/editing, completion, and release of documents, engineering change orders ECR’s and Deviation change proposals and data packages.Responsible for logging, filing and tracking all necessary drawings, documents, barcode labels, software and commercial part approval form and the supporting vendor’s data sheet which allows an entry of component into the Approved Vendor List (AVL).

Scanning all controlled documents. Maintain procedures for storage, retention and destruction of company records.Implemented SOP procedures and maintain close relationships with vendors and our Manufacturing staff in Linear Hong Kong.

Dj Orthopedics, LLC, Vista, California 06/1997 – 11/2005

Sr. Document Control Analyst

BRACING AND SUPPORT/CUSTOM BRACING FOR ATHELETES

Review, analyzes and verify with the new/existing release of documentation in accordance with SOPs.Ensure requirements of initiator/requester of the Change Orders are met. Coordinate and maintain new and existing part number issuance. Supervised employees on systems.

Update master database, Coordinate with purchasing, engineering and vendors on drawings and follow up status on lead-time.Communicate change order information and interface with engineering organizations. (Manufacturing Engineering and Design Engineering), Managers, Manufacturing, Purchasing, Production, Planning, Quality, Marketing/Sales, Customer Service and Office Care.Coordinate new project designs with engineering, manufacturing and marketing. Maintain routing and review all multi-level Bill of Materials and labels. Support compliance departments during regulatory inspections/audits/calibration. Maintain Device Master and Device History Records. Maintain document control records and prepare document packages for routing signatures and manufacturing labels (translations in 5 different languages). Trained employees on GMPs, SOP’s and FDA laws. Administer training for new procedures to documentation changes/deviations. Manager calendar set up for meetings and ordered office supplier.

Block Medical, Carlsbad, California 05/1991 – 05/1997

Sr. Document Control Specialist/Supervisor

HOME PUMP INFUSION

Coordinated and maintained all new part number issuance for new and existing products.

Release change orders by ensuring the request meets the change control policies, procedures and regulation standards as well as supporting quality engineering, quality control activities.

Managed preparation of documentation closure of regulatory commitments, contracts and submissions.Developed systems to ensure effective, timely document reconciliation including, SOPs, Controlled Forms, deviations, Device Master and History Records and Technical Files. Trained new employees on the ECO processes of CAPA – Corrective and Preventive Action. Label and packaging on all incoming SOP’s in clean room environment. Review and disposition of batch records.Monitor ECO’s through Electronic Data Management Systems (EDMS).

Hughes Aircraft, Carlsbad, California 01/1983 – 04/1991

Configuration management

DEFENSE MILITARY CONTRACTS

Maintained documentation control and highly confidential intellectual property data/ files, Government secret clearance.

Preparation and review of all multi-level bills of materials. Purchasing for all Engineering Department.

Strong understanding of GMP. Filing, reading engineering drawings, specifications and bill of materials. Responsible for obsolescence/history of part numbers in a database system.

Supervised cross-functional training for new products and contracts and Maintained document control records, prepared document packages for routing and approvals and maintained Device Master and Device History Records.

Attended training classes on documentation, ISO and cGMPs.

Maintained all new product labeling and translations.

Trained employees on cGMPs and SOPs.

Technical Skills:

Opening day at Del Mar Race track 2020 and 2021 waitress Turf Club

Recruiting new vendors

Ability to multi-task and prioritize work

Proficient with Microsoft office applications

DocStar Electronic record storage/retrieval

Bartender (GTIN/UDI labels)

Highly computer literate

70 wpm, 10 key by touch

Excellent organizational and communication skills

Highly organized

Strong written, verbal, problem solving/decision making and analytical skills

Training Classes:

20 years FDA Quality System Regulations and ISO standards (ISO 17025, 21 CFR Part 820 (cGMP), ISO 13485, ISO 9001,15189.

Good working knowledge of ERP/MRP systems

Experience SAP/Agile PLM systems

Experience with delivering training material to groups

Excellent root cause analysis, problems solving and analytical skills

ViaSat University Microsoft word/excel/oracle agile experience

2 Secret Clearance (Viasat and Hughes Aircraft)

Training/Experience with CAPA

QC/QA experience in an FDA regulated environment

Experience with maintaining and administrating an EDMS (Electronic Data Management System).

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