Manufacturing Labeling Specialist

5 days ago

Rocklin, United States MilliporeSigma Full time

** Please note, this is a temp-to-hire position with a possibility of conversion or extension.

Location: Rocklin, CA

Shift: 1st shift, Monday - Friday.

**Key Responsibilities**:
The Mfg Labeling Specialist performs laboratory activities in the manufacturing lab including Buffer and antibody manufacturing. The technician follows the manufacturing schedule to complete required tasks and is responsible for following standard operating procedures involving basic laboratory techniques, calculations, material measurements operation of laboratory equipment and record keeping as necessary.

JOB RESPONSIBILITIES:

- Manufactures, and packages products following SOPs
- Use local ERP systems to accurately document manufacturing processes
- Maintains records and keeps spreadsheets updated
- Escalates any non-conforming products to management, participate in the investigation process
- Facilitate in the development of documents, and update documents pertaining to lab procedures and product manufacturing to maintain cGMP and ISO compliance, and increase efficiency.
- Ensure all quality requirements and scheduled deadlines are met. Managing time and priorities to meet deadlines
- Complete all work in compliance with established cGMP, FDA, OSHA, USDA, EPA, ISO and Quality System regulations, as applicable, to assure output meets established quality and regulatory specifications.
- Assist in training other staff members as requested.
- Cleaning of labware as well as general lab cleaning, maintains lab cleanliness and complies with cGMP compliance
- Provide equipment maintenance as necessary
- Meets productivity standards and strives to increase productivity without sacrificing quality and safety
- Looks for ways to improve and promote quality
- Demonstrates accuracy and thoroughness
- Troubleshoot equipment problems
- May require work on various projects to improve efficiency or compliance
- Other duties as assigned or required
- Follow regulatory and standard requirements as applicable to the site, i.e., MDSAP, ISO 13485, IVDR, and compliance with the site Quality Manual.
- Other duties as assigned.

EDUCATION & EXPERIENCE:

- AA/AS in a biological science or biochemistry field OR High School Diploma or GED and 3 years of lab experience in a related discipline which supports performance of required tasks in a final production role
- 1 year of production experience is required
- Knowledge of FDA QSRs and ISO 13485 or other related industry standards preferred; experience with SAP or other ERP system is strongly preferred
- Previous experience in FDA regulated biotechnology or pharmaceutical environment is strongly preferred

KNOWLEDGE, SKILLS & ABILITIES:

- Good computer skills, including MS Office
- Good organizational skills and attention to detail
- Good verbal and written communication skills including the and accurately complete batch records
- Knowledge of SAP NEXT strongly preferred

MilliporeSigma is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.

**Job Types**: Full-time, Contract

Pay: $24.00 - $26.00 per hour

Expected hours: 40 per week

Schedule:

- 8 hour shift
- Monday to Friday

**Education**:

- Bachelor's (required)

**Experience**:

- ERP systems: 1 year (required)
- Documentation review: 1 year (preferred)

Ability to Commute:

- Rocklin, CA (required)

Work Location: In person

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