Adam Baca Email & Phone Number

Durham, North Carolina, Us

Bothell, Wa, Us

Basel, Baselstadt, Ch

Planned, scheduled, and supported daily production tasks to schedule and execute a successful GMP (Good Manufacturing Practices) campaign that complied with company standards. Facilitated additional manufacturing activities and reinforced other manufacturing groups (MS&T, PD, QA, Maintenance, and Microbiology). • Carried out 100% successful completions of all executed lots in the Cell Expansion Dept. 113 lots for 2020 – 2021.• Supervised, coached, mentored and trained team members to ensure staff maintained a high level of compliance to procedures and quality expectations. • Ensured equipment and manufacturing facilities remained in working order by overseeing production technician, maintenance, cleaning, and ensuring submitted work orders for facility and equipment maintenance and repair in a timely manner.• Qualified on all department floor operations to assist in maintaining the production schedule

Durham, North Carolina, Us

Developed and provided continuous improvement of the GMP Training Program.• Developed training materials and provided guidance in development and implementation of a consistent training program. Developed Qualified Trainer Program the Colorado facility. • Assessed new and existing training materials to ensure user and company needs were met and helped design and develop classroom, eLearning, and On the Job Training (OJT) materials.• Facilitated new-hire training and annual classroom training that included updated and training documentation, job descriptions / data entry through task-based training modules. Completed NEO (New Employee Orientation) training for over 130 employees in 2018.• Helped design and implement electronic training assignments and tracked progress.

Santa Clara, Ca, Us

Scheduled and trained NASD staff on new employee orientation, GMP / GDP training and other programs that included contractors and External workers. • Assigned training plans for all new employees per position descriptions. Developed training rubrics and trainer guidelines; participated in client audits, evaluated existing training and served as a qualified trainer for floor operations. • Developed Boot Camp program and created training matrix to track training progress.• Helped create the Qualified Trainer Program (QTP) and guidelines for training uniformity.

Santa Clara, Ca, Us

Supported release of final API (Active Pharmaceutical Ingredient) materials to meet client and manufacturing production timelines. Performed daily manufacturing floor audits. • Performed document reviews on all related materials to complete API; wrote and approved SOPS, batch records, and processing forms.• Provided support on quality issues that ensured accuracy / reliability of company products.

Thousand Oaks, Ca, Us

Maintained manufacturing production schedule to avoid production delays. Participated in cross-functional meetings to coordinate plant activities (e.g. maintenance, utilities, plant shut downs).• Provided daily shift updates and assigned tasks to staff and as the (RBI) Flex Force Lead, assigned, scheduled and trained 58 volunteers monthly for processing operations.• Acted as Department Safety Representative; assisted with job hazards (JHAs), SOPs, and lockout / tagouts (LO/TO). • Directed area audits between sites to ensure compliance on site procedures via the Amgen Inspection Readiness Program (AIRP).• Operation of various pieces of equipment to include, Fermenters, Chromatography Skids, Purification Columns, Column Packing, Buffer/Media Tanks, Bio-reactors, Centrifuges, UF/DF Skids, Viral Inactivation, etc..

Basel, Basel-Stadt, Ch

Process Development Tech (1998 - 2002)Work alongside Process Develop Scientists in the manufacturing of finish dosage products. To provide feedback and process improvements when moving from small scale manufacturing to large scale production. To help in the approval process and first to file by developing batch records and SOPs to ensure a smooth transition, other duties included:• Batch Record Review• Packaging/Shipping of sensitive material• Perform process investigations, equipment qualification, validation and internal audits• Operation of various pieces of equipment, dispensing of liquid & dry components • Production process testing• Forklift CertifiedGranulation Tech III (1992- 1998) The manufacture of pharmaceutical oral dosage forms by using Granulation Process Principles. Types of mixing included; dry mixing, low shear wet granulation, high shear granulation, top spray granulation, key process equipment included:• Horizontal Mixers• Vertical Mixers• Glatt Fluid Bed Granulation system• Co-Mills, Fitz-Mills, vBlenders• Sieve Analysis testing, Moisture testing