Posted in Other 28 days ago.
Location: Thousand Oaks, California
Innova Solutions is immediately hiring Manufacturing Senior Associate
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Position type: Fulltime - Contract
Duration: 6 Months
Location: Thousand Oaks CA 91320 (Onsite)
As Manufacturing Senior Associate
, you will:
Job Description:
Responsibilities include, but not be limited to; New Product Introductions (NPI) program management and non-capitol project management. The individual will be responsible for leading projects of diverse subjects and complexity and have proven strong communication and collaborative capabilities, both within and outside of the immediate team. The Sr Associate, Manufacturing will successfully inform, influence, and assign accountability to members of cross-functional teams that include; Manufacturing, Plant Quality Assurance, Process Development, Clinical Process Engineering, Analytical Sciences, Quality Control, Supply Chain, and Regulatory Affairs.
Job Responsibilities:
• Change control ownership, ensuring records are comprehensive and compliant per GMP regulatory procedures. This must occur with a Right the First-Time approach.
• Strong project management skills, with prior project experience preferred.
• Timely closure of change control records in relation to procedural guidance and/or disposition timelines
• Represent Building 20 Manufacturing as the receiving site for incoming Technology Transfers/New Product Introductions into Building 20
• Identifying improvement opportunities within the organization and take pro-active steps to build consensus to implement those opportunities
• Succinctly communicate verbally and in writing to staff and leadership
• Presenting records and business processes to a variety of audiences, including auditors and inspectors
• Participating/leading Continuous Improvement Transformation activities
• Champion safety and compliance at all times
Preferred Qualifications:
• Masters Degree
• Experience with PAS X Werum software for electronic batch records
• Technical understanding of Drug Product (DP) manufacturing operations, such as buffer batching, DP formulation, DP Filling, Inspection
• Experience leading change controls in Trackwise
• Degree in life sciences or engineering
• Strong scientific, technical interactions with partner organizations such as Process Development, Process Engineering, Supply Chain, Quality Control, Regulatory
• Demonstrated technical writing skill
• Demonstrated ability to work in a team.
Thank you!
Lailun Sheikh
Senior Associate, Recruitment
Phone: 412-763-1477
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PAY RANGE AND BENEFITS:
Pay Range*: ? $30.00-$35.00/Hour.
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
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Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
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ABOUT INNOVA SOLUTIONS:Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.
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