Please note that this is a 1 year contract position.
- Position sites onsite 100% of the time
- 3RD SHIFT ROLE (Sun night 10:00pm - Fri morning 6:30am)
- Train on 1ST Shift for about 8 weeks (Mon - Fri from 8am-5pm)
- Will support manufacturing shop floor
- Bachelor's degree is required
- About 2 years of experience is preferred
- Will be reviewing Batch Records
- Will help oversee the manufacturing floor
- Must have experience with Quality and GMP knowledge
- Liquid experience a plus but not required, would take solid experience as well)
- Must be a critical thinker
• The position is responsible for providing daily Quality Assurance support to the manufacturing site to ensure internal and regulatory cGMP and CFR requirements are met. Quality Assurance support areas include but are not limited to Batch Record Review, Product Release, Standard Operating Procedures, Investigations, CAPA, Change Control, Shop Floor Audits. The position will interact with other departments including Manufacturing, Packaging, Quality Laboratories, Quality Systems, Validation, Engineering, Maintenance and other departments as it relates to site Quality Assurance responsibilities. The Company’s management reserves the right to add, delete or otherwise alter assigned duties at any time. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. III.
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: All employees
o Attend GMP training on the schedule designated for my role and as appropriate for my role.
o Adhere to strict compliance with procedures applicable to my role.
o Exercise the highest level of integrity in the tasks that is performed.
o In a timely and prompt manner, identify, report and seek correction for deviations noted in my workplace.
o Embrace a behavior of employee involvement and commitment to doing the job right the first time.
1. Quality Assurance and Compliance Focus
• Provides daily ‘Shop Floor” QA support to warehouse, bulk manufacturing and packaging lines.
• Provides leadership support to QA Shop Floor activities including communication of quality events to management.
• Performs or supports activities related to Batch Record Review, Raw Material, Bulk, and Finished Product Releases.
• Provides support to Investigations and/or Investigation Protocols..
• Performs or supports activities related Line Audits, Line or Area Cleaning Verifications
• Participates in design of quality processes and creation/modification/approval of Standard Operating Procedures (SOP’s).
• Provides support to Consumer Complaint investigations.
• Provide QA support to various project teams, as needed.
• Actively supports Site metrics, compliance improvement and training initiatives.
2. Customer and Performance Improvement Focus
• Provide support to capturing of site metrics and promote improvement opportunities.
• Facilitate resolution of issues to improve site metrics.
3. People & Organization Focus
• Provides training and direction as needed to new employees
• Teams with Department members for process feedback and continuous improvement opportunities
• Represents Quality Assurance in positive manner
4. Performs other related duties as required.
• BS/BA College Degree with 2 years of related Industry Experience, with proven success in cGMP/compliance environment
• Active cGMP Interpretation and Application Experience
• Demonstrated leadership- possesses the ability to lead a team
• Strong Organizational Skills
• Strong Communication/Interpersonal and Facilitation Skills (verbal, written and presentation)
• Problem Solving/Investigation Experience preferred
• Expertise in Handling Multiple Priorities Physical Demands: N/A
Knowledge, Skills and Abilities:
• Minimum Bachelor College Degree preferably in a Science
• 2 + years professional experience in a regulated industry
• Process and Systems Experience, especially with SOPs, MBRs, Change Controls, Non-Conformance Investigation Documentation
• Experience with Liquid Dose processing and packaging technology preferred.
• Validation Experience preferred
Global Leadership Profile Requirements: N/A
Other Requirements: N/A
Applicants must provide their phone number. Reference job number A1967.