Job Description

Description:
Note:
NIGHT SHIFT ADD 15% DIFFERNTIAL.
ONSITE 100% - PQA Sr. Associate (Nights)- No remote work
12-hour night shifts (7:00 PM - 7:00 AM) on a rotating schedule.

• The ideal candidate is someone with prior experience working night shifts in a biotech or pharmaceutical GMP-regulated environment and is fully comfortable with the rotating 12-hour schedule (7:00 PM - 7:00 AM). 
• They should have a strong understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) to efficiently review batch records, logbooks, and on-the-floor QA processes. 
• While a scientific academic background (e.g., chemistry, biotechnology) is preferred, hands-on industry experience can compensate for the lack of a degree. 
• The candidate must be a strong communicator and a team player, capable of working cross-functionally with both the QA and manufacturing teams while effectively documenting and relaying information during shift handovers. 
• Given the challenges past hires have faced in adjusting to the night schedule, a proven ability to work nights long-term is critical to ensure continuity in this role.
• QA Senior Associate will be responsible for Quality On the Floor in support of Manufacturing activities. 
• This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate batch record and attachment reviews, logbook reviews, area changeover reviews, real-time decision-making regarding quality incidents.
• This is a unique opportunity to foster a strong partnership and learning environment between Manufacturing and Quality staff. 
• This position works a rotating night shift (C shift), with five day working during one week (M, Tu, F, Sa, Su) and two days the following week (W, Th), shift hours are 7pm to 7am, with adaptability as required based on the business needs, provides coaching, guidance and direction to Manufacturing and Facilities & Engineering staff in regards to compliance and quality systems.

Basic Qualifications

• Master’s degree OR Bachelor’s degree and 2 years of experience (in QA or MFG) OR Associate’s degree and 6 years of experience (in QA or MFG).
• Has worked in similar drug manufacturing organization, within Quality or MFG for at least 2 years, has Academic background in any Sciences discipline.

Top 3 Must Have Skill Sets:

• Familiar with GxPs, industry practices and basis regulations.
• Has worked in Biotech/ Pharma industry.
• Academic background in Sciences

Pay Rate between $35 - $40/Hr on W2 based on experience.

"This posting is for Contingent Worker, not an FTE"

Job Tags

Shift work, Night shift, Rotating shift, 2 days per week,

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