Job Details
Manufacturing Contract Associate I (PROCESSING and PACKAGING) (3 Day Shift / 3 Night Shift)
Under moderate supervision, perform all responsibilities necessary to operate, troubleshoot, set up,
djust, repair and maintain equipment and execute the manufacturing processes. Perform a variety of
tasks including but not limited to process execution and monitoring to assure product quality and
manufacturing throughput. Perform routine cleaning, housekeeping and non-routine maintenance with
dherence to all safety, environmental and quality policies and procedures. This role will also move
material and product to and from work centers within the manufacturing site.
Responsibilities: Under limited supervision and in accordance with all applicable federal, state and local
laws/regulations, the Companies' policies, procedures and guidelines, this position:
Ensure quality and compliance in all my actions by:
Attend GMP training on the schedule designated for my role and as appropriate for my role
Adhere to strict compliance with procedures applicable to my role.
Exercise the highest level of integrity in the tasks that I perform
Work with the team to ensure all aspects of the business remain compliant and in an audit ready state
In a timely and prompt manner, identify report and seek correction for deviations noted in my
workplace.
Embrace a behavior of employee involvement and commitment to doing the job right the first time
Material Handling, Staging, Order, Return and Good Receipt
Perform a combination of manual tasks including but not limited to feeding, dispensing, charging,
mixing, sorting, inspecting, assembling, and picking.
Execute the manufacturing and packaging operation with an adequate supply of components using
mechanical apparatus, automated equipment and manual processes.
Accurately complete paperwork and electronic transactions for all documentation requirements
including but not limited to SAP transactions, batch record steps and paper and electronic logbooks.
Perform the final checks and verifications for operations as indicated in the batch records and SOPs
Order and receive material and perform the required identification and use ( i.e. RFI system and basic
SAP)
Operate forklift, manual and motorized pallet jacks. Maintain proper inventory levels of clean tools
including ancillary equipment, pallets and containers.
Manage the removal of waste and execute equipment cleaning and housekeeping operations in
ccordance to policies and procedures.
Partner with supervision to ensure daily requirements are met.
Dispensing, Compounding, Mixing, and Packaging
Provide communication for product quality impact in case of deviations and provide the proper
escalation to direct supervisor. Manufacturing first line operation SME in deviation events and
product quality assessments.
Able to read and apply instruction from paper or electronic batch record. Using basic knowledge of
mathematics and simple chemistry, measure or weigh required quantities of raw materials. This may
include the calculation to adjust dispensed quantity based on material potency as per batch record and
SOP directives. Accurately document quantities dispensed and charged.
Coordinate with engineering and management to validate new equipment, tooling, system controls,
nd validate new product codes.
Support numerous production line activities such as line tests, qualifications, validation, and
improvements.
Drive OEE including the identification of opportunities to improve production and efficiency in a
compliant safe manner.
Complete other ad-hoc tasks as required.
Equipment Cleaning
Load, operate and unload the automated washers as per procedures.
Disassemble/assemble equipment to facilitate cleaning. Perform manual cleaning of ancillary
equipment, room/suite, bulk truck sampling device, packaging line, and transfer equipment. Utilize
control system to clean major equipment (CIP/COP).
Complete visual verification of cleaning and document these steps in the appropriate system.
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Housekeeping
Perform general housekeeping activities at the expected level to comply with cGMP and EHS
requirements. Perform periodic cleaning to maintain room/zone requirement as per applicable
procedures.
Document cleaning as required in the appropriate system.
IPC Testing and Samples
Checks, samples, test material and in process product controls using basic knowledge of chemistry,
mathematics and makes adjustments according to the validation parameters for the specific product
nd process. Provide first line of assessment for product quality impact in case of deviation and
provide the proper escalation to direct supervisor. Primary Manufacturing first line operation SME in
deviation event and product quality assessment
Report deviations and escalate to supervision. Support deviation and non-conformance investigations.
Perform required check/sampling and testing as per batch record and SOP directives
Computerized Systems Knowledge
Trained to the role in which you are assigned as required for your job function in the applicable
systems
Utilize MS office and other systems to improve business effectiveness
Working knowledge of ERP and MES systems.
Product Knowledge
Have knowledge of the product family, product size and put-up, product critical characteristics (i.e.
color, viscosity) and basic understanding and knowledge of the product composition (i.e. active,
excipient, components, etc.).
Have an understanding of the critical parameters associated with all processing steps.
Training
Partner with the training department to create training materials.
Participate in all trainings
Ensure all training is completed on time
Investigations
Assist in gathering and compiling information.
Participate in investigations.
Compliance- Safety, GMP, Facilities
Lead areas in ensuring all operations are done in a compliant and safe manner.
Assist in coordination efforts in case of emergency, as appropriate - spill, fire etc.
Take necessary action to eliminate and immediately address safety hazards.
Communicate any observed unsafe behaviors immediately.
Understand the safety concerns and promote a safety conscious culture within their job function.
Wear the appropriate PPE when working in manufacturing and other hazardous working
environments and advocate standards of safety.
Contribute to and attend all EHS programs as assigned.
Promptly communicate deficiencies to management.
Maintain facility in good working condition.
Works with team to ensure all aspects of business remain compliant.
Attending GMP training on the schedule designated for the role.
Adhering to strict compliance with procedures according to the roles and responsibilities.
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In a timely and prompt manner, identify report and seek correction for deviation noted in the
workplace.
Documentation Management
Escalate document errors to supervision for correction or update.
Perform/assist in the completion, review and documentation of the manufacturing and processes steps
s per the batch record and SOP directives. Always follow GMP documentation requirements.
Document all activities GMP requirements.
Leadership
Assist management through change and transformation.
Attend meetings as the manufacturing representative as needed.
Exhibits and lives core values and behaviors.
Continuously demonstrates all Global Leadership Profile values. Expectations of a Global Leadership
Profile leader: fairness, honesty, consistent and ethical behaviors, empathy, and people skills.
Contributes and supports an environment that fosters diversity and inclusion.
Contributes to a climate of open communication, engagement and ownership within team.
Provide feedback to site management.
Builds working relationships.
Supports strategic and tactical plans in alignment with site's mission and plans.
Requirements: (List types of requirements and typical years required)
Education: High school diploma/secondary education or equivalent and/or associates degree or Bachelor's
degree.
Experience: 2-4 years of experience in a manufacturing environment, Pharmaceutical/GMP experience
preferred.
Physical Demands: Candidates must be able to meet the physical demand of that this position requires:
continuous lifting and/or moving from 5 to 25lbs. weight material, and frequent lifting or moving average
(25-50 lbs) weight material.
Knowledge, Skills and Abilities: Must have a proven ability to interact with other operators, management,
nd groups inside and outside of Manufacturing. Candidates must have a basic working knowledge of Microsoft
Word and Excel.